Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095D
Reason: Incomplete insertion of the patient connector of the
Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: US Nationwide distribution.Recall #Z-3174-2024 Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095DA
Reason: Incomplete insertion of the patient connector of the
Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: US Nationwide distribution.Recall #Z-3175-2024 Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 15, 2024
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095L
Reason: Incomplete insertion of the patient connector of the
Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: US Nationwide distribution.Recall #Z-3176-2024 Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 15, 2024
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095W
Reason: Incomplete insertion of the patient connector of the
Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: US Nationwide distribution.Recall #Z-3177-2024 Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2010M2096
Reason: Incomplete insertion of the patient connector of the
Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: US Nationwide distribution.Recall #Z-3178-2024 Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2010M2096A
Reason: Incomplete insertion of the patient connector of the
Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: US Nationwide distribution.Recall #Z-3179-2024 Open, ClassifiedPosted Sep 19, 2024·Initiated Jul 10, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
Reason: Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.Recall #Z-3180-2024
Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 27, 2024
HAWK Warming Grid, Item Number: 59-300
Reason: Incorrect expiration date.
Root cause: Process control
Recalling firm: Safeguard US Operating LLCType: Pack, Hot Or Cold, DisposableDistribution: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.Recall #Z-3181-2024
Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 27, 2024
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Reason: Incorrect expiration date.
Root cause: Process control
Recalling firm: Safeguard US Operating LLCType: Pack, Hot Or Cold, DisposableDistribution: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.Recall #Z-3182-2024
Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 27, 2024
Kits of Convenience containing 1 of the 2 Item Numbers:
1. Item Number: 59-300 HAWK Warming Grid,
2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set.
Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC);
Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).
Reason: Incorrect expiration date.
Root cause: Process control
Recalling firm: Safeguard US Operating LLCType: Pack, Hot Or Cold, DisposableDistribution: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.Recall #Z-3183-2024
Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 20, 2024
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Reason: Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Root cause: Process control
Recalling firm: Cypress Medical Products LLCType: Antisera, All Groups, Streptococcus Spp.Distribution: US Nationwide distribution.Recall #Z-3184-2024
Open, ClassifiedPosted Sep 19, 2024·Initiated Aug 20, 2024
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Reason: Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Root cause: Process control
Recalling firm: Cypress Medical Products LLCType: Antigens, All Groups, Streptococcus Spp.Distribution: US Nationwide distribution.Recall #Z-3185-2024
Open, ClassifiedPosted Sep 19, 2024·Initiated Jul 23, 2024
VariSoft Infusion Set, Single Use.
Reason: Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Root cause: Process change control
Recalling firm: Unomedical A/SType: Set, Administration, IntravascularDistribution: US Nationwide distribution in the state of California.Recall #Z-3186-2024
Open, ClassifiedPosted Sep 18, 2024·Initiated Aug 22, 2024
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azurion 3 M15 722221 Azurion 3 M12 722079 Azurion 7 M20 722078 Azurion 7 M12 722068 Azurion 7 B20 722067 Azurion 7 B12 722064 Azurion 3 M15 722063 Azurion 3 M12
Reason: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Nationwide, Canada and Worldwide:
Albania
Algeria
Argentina
Armenia
Australia
Austria
Azerbaijan
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Brunei Darussalam
Bulgaria
Cambodia
Cayman Islands
Chile
China
Colombia
Costa Rica
C¿te D'Ivoire
Croatia
Cuba
Curacao
Cyprus
Czech Republic
Denmark
Dominican Republic
Ecuador
Egypt
Estonia
Ethiopia
Fiji
Finland
France
French Polynesia
Georgia
Germany
Ghana
Gibraltar
Greece
Guadeloupe
Guinea
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Korea, Republic of
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Libya
Lithuania
Macao
Macedonia
Malaysia
Maldives
Malta
Martinique
Mauritania
Mauritius
Mexico
Mongolia
Morocco
Myanmar
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Norway
Oman
Pakistan
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
R¿union
Romania
Russian Federation
Saudi Arabia
Senegal
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sudan
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tanzania
Thailand
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Venezuela
Viet Nam
Virgin Islands (U.S.)
YemenRecall #Z-3165-2024
Open, ClassifiedPosted Sep 18, 2024·Initiated Aug 22, 2024
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 722028 Allura Xper FD20 722027 Allura Xper FD10/10 722026 Allura Xper FD10 722025 Allura Xper FD20 Biplane OR Table 722023 Allura Xper FD20 OR Table 722020 Allura Xper FD20 Biplane OR Table 722015 Allura Xper FD20 OR Table 722013 Allura Xper FD20 Biplane 722012 Allura Xper FD20 722011 Allura Xper FD10/10 722010 Allura Xper FD10 722008 Allura Xper FD20 Biplane 722006 Allura Xper FD20 722005 Allura Xper FD10/10 722003 Allura Xper FD10 722002 Allura Xper FD10F 722001 Allura Xper FD10C
Reason: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Nationwide, Canada and Worldwide:
Albania
Algeria
Argentina
Armenia
Australia
Austria
Azerbaijan
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Brunei Darussalam
Bulgaria
Cambodia
Cayman Islands
Chile
China
Colombia
Costa Rica
C¿te D'Ivoire
Croatia
Cuba
Curacao
Cyprus
Czech Republic
Denmark
Dominican Republic
Ecuador
Egypt
Estonia
Ethiopia
Fiji
Finland
France
French Polynesia
Georgia
Germany
Ghana
Gibraltar
Greece
Guadeloupe
Guinea
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Korea, Republic of
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Libya
Lithuania
Macao
Macedonia
Malaysia
Maldives
Malta
Martinique
Mauritania
Mauritius
Mexico
Mongolia
Morocco
Myanmar
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Norway
Oman
Pakistan
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
R¿union
Romania
Russian Federation
Saudi Arabia
Senegal
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sudan
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tanzania
Thailand
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Venezuela
Viet Nam
Virgin Islands (U.S.)
Yemen
Open, ClassifiedPosted Sep 18, 2024·Initiated Aug 22, 2024
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C
Reason: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Nationwide, Canada and Worldwide:
Albania
Algeria
Argentina
Armenia
Australia
Austria
Azerbaijan
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Brunei Darussalam
Bulgaria
Cambodia
Cayman Islands
Chile
China
Colombia
Costa Rica
C¿te D'Ivoire
Croatia
Cuba
Curacao
Cyprus
Czech Republic
Denmark
Dominican Republic
Ecuador
Egypt
Estonia
Ethiopia
Fiji
Finland
France
French Polynesia
Georgia
Germany
Ghana
Gibraltar
Greece
Guadeloupe
Guinea
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Korea, Republic of
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Libya
Lithuania
Macao
Macedonia
Malaysia
Maldives
Malta
Martinique
Mauritania
Mauritius
Mexico
Mongolia
Morocco
Myanmar
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Norway
Oman
Pakistan
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
R¿union
Romania
Russian Federation
Saudi Arabia
Senegal
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sudan
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tanzania
Thailand
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Venezuela
Viet Nam
Virgin Islands (U.S.)
YemenRecall #Z-3167-2024
Open, ClassifiedPosted Sep 18, 2024·Initiated Aug 22, 2024
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva
Reason: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: System, X-Ray, StationaryDistribution: Nationwide, Canada and Worldwide:
Albania
Algeria
Argentina
Armenia
Australia
Austria
Azerbaijan
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Brunei Darussalam
Bulgaria
Cambodia
Cayman Islands
Chile
China
Colombia
Costa Rica
C¿te D'Ivoire
Croatia
Cuba
Curacao
Cyprus
Czech Republic
Denmark
Dominican Republic
Ecuador
Egypt
Estonia
Ethiopia
Fiji
Finland
France
French Polynesia
Georgia
Germany
Ghana
Gibraltar
Greece
Guadeloupe
Guinea
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Korea, Republic of
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Libya
Lithuania
Macao
Macedonia
Malaysia
Maldives
Malta
Martinique
Mauritania
Mauritius
Mexico
Mongolia
Morocco
Myanmar
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Norway
Oman
Pakistan
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
R¿union
Romania
Russian Federation
Saudi Arabia
Senegal
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sudan
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tanzania
Thailand
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Venezuela
Viet Nam
Virgin Islands (U.S.)
YemenRecall #Z-3168-2024
Open, ClassifiedPosted Sep 18, 2024·Initiated Aug 15, 2024
Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
Reason: Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.
Root cause: Nonconforming Material/Component
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Canada, Chile, Colombia, Croatia, Cura¿ao, St. Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong¿Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Mexico, Morocco, Netherlands, New¿Zealand, Norway, Oman, P.R.¿China, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Republic¿Korea, Romania, Russian¿Fed., Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan,
Thailand, Tunisia, Turkey, U.A.E, United¿Kingdom, Uruguay, Vietnam, Zaire.
¿¿¿¿¿¿Recall #Z-3169-2024 Open, ClassifiedPosted Sep 18, 2024·Initiated Aug 15, 2024
ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.
Reason: Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.
Root cause: Nonconforming Material/Component
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Canada, Chile, Colombia, Croatia, Cura¿ao, St. Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong¿Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Mexico, Morocco, Netherlands, New¿Zealand, Norway, Oman, P.R.¿China, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Republic¿Korea, Romania, Russian¿Fed., Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan,
Thailand, Tunisia, Turkey, U.A.E, United¿Kingdom, Uruguay, Vietnam, Zaire.
¿¿¿¿¿¿Recall #Z-3170-2024 Open, ClassifiedPosted Sep 17, 2024·Initiated Aug 5, 2024
ERIC Retrieval Device REF:
ER173020
ER174030
ER176044
The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke.
Reason: Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
Root cause: Under Investigation by firm
Recalling firm: MICROVENTION INC.Type: Catheter, Thrombus RetrieverDistribution: U.S. Nationwide distribution in the states of AR, CA, FL, IN, LA, MA, MN, MO, NC, NJ, NY, OH, PA, SC, TX and VA.Recall #Z-3157-2024