Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 5, 2024
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.Recall #Z-2965-2024 Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 5, 2024
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.Recall #Z-2966-2024 Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 5, 2024
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.Recall #Z-2967-2024 Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 5, 2024
Impella 5.5 Set AU; Product Code: 1000361;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.Recall #Z-2968-2024 Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 5, 2024
Impella CP Smart Assist Set; Product Code: 1000402;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.Recall #Z-2969-2024 Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 5, 2024
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.Recall #Z-2970-2024 Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 5, 2024
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.Recall #Z-2971-2024 Open, ClassifiedPosted Sep 3, 2024·Initiated Jul 25, 2024
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Reason: There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Root cause: Under Investigation by firm
Recalling firm: Breas Medical, Inc.Type: Continuous, Ventilator, Home UseDistribution: US Nationwide.Recall #Z-2690-2024
Open, ClassifiedPosted Aug 30, 2024·Initiated Mar 5, 2024
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason: Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
Root cause: Process control
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.Recall #Z-1546-2024
Open, ClassifiedPosted Aug 30, 2024·Initiated Jul 1, 2024
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers:
United States:
BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A
BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A
BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A
BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A
BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A
BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A
BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A
BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A
BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A
BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A
Japan:
BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
Reason: Due to packaging defects, sterility assurance and heparin activity may be compromised.
Root cause: Package design/selection
Recalling firm: W L Gore & Associates, Inc.Type: Iliac Covered Stent, ArterialDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.Recall #Z-2945-2024
Open, ClassifiedPosted Aug 30, 2024·Initiated Jul 1, 2024
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers:
United States:
BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C
*For Clinical use.
Reason: Due to packaging defects, sterility assurance and heparin activity may be compromised.
Root cause: Package design/selection
Recalling firm: W L Gore & Associates, Inc.Type: Iliac Covered Stent, ArterialDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.Recall #Z-2946-2024
Open, ClassifiedPosted Aug 30, 2024·Initiated Jul 9, 2024
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
Root cause: Software design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.Recall #Z-2947-2024
Open, ClassifiedPosted Aug 30, 2024·Initiated Jul 9, 2024
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
Root cause: Software design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.Recall #Z-2948-2024
Open, ClassifiedPosted Aug 29, 2024·Initiated Jul 24, 2024
McKesson Syringe 60CC, Luer Lock Tip, Sterile,
ITEM NO 102-S60C.
Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Reason: Affected syringes lack FDA clearance.
Root cause: Other
Recalling firm: Cypress Medical Products LLCType: Syringe, PistonDistribution: US distribution only. Domestic distribution nationwide.Recall #Z-2940-2024
Open, ClassifiedPosted Aug 29, 2024·Initiated Jul 4, 2024
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Reason: During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
Root cause: Process control
Recalling firm: ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICALType: Orthopedic Manual Surgical InstrumentDistribution: Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.Recall #Z-2941-2024
Open, ClassifiedPosted Aug 28, 2024·Initiated Apr 8, 2024
Medline procedural kits labeled as:
1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F;
2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: WorldwideRecall #Z-2739-2024
Open, ClassifiedPosted Aug 28, 2024·Initiated Apr 8, 2024
Medline procedural kits labeled as:
1) BABY CARE KIT UNIV, Pack Number DYKL1025;
2) BABY CARE KIT UNIV, Pack Number DYKL1025H
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Support, Patient PositionDistribution: WorldwideRecall #Z-2740-2024
Open, ClassifiedPosted Aug 28, 2024·Initiated Apr 8, 2024
Medline procedural kits labeled as:
PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Spinal Epidural Anesthesia KitDistribution: WorldwideRecall #Z-2741-2024
Open, ClassifiedPosted Aug 28, 2024·Initiated Apr 8, 2024
Medline procedural kits labeled as:
1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865;
2) CIRCUMCISION TRAY, Pack Number CIT6715;
3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiac Catheterization KitDistribution: WorldwideRecall #Z-2742-2024
Open, ClassifiedPosted Aug 28, 2024·Initiated Apr 8, 2024
Medline procedural kits labeled as:
1) OPEN HEART PEDS, Pack Number CDS981050Q;
2) OPEN HEART CDS, Pack Number CDS982411N;
3) OPEN HEART, Pack Number CDS983348AA;
4) OPEN HEART, Pack Number CDS983348X;
5) OPEN HEART, Pack Number CDS983348Y;
6) HMT CV SET UP CDS, Pack Number CDS984206R;
7) OPEN HEART PEDS PACK, Pack Number CMPJ01037P;
8) OPEN HEART A&B PACK, Pack Number CMPJ02162I;
9) HMT SMALL TABLE PACK, Pack Number CMPJ03510J;
10) MAJOR VASCULAR PACK, Pack Number CMPJ06631C;
11) VASCULAR PACK, Pack Number CMPJ08949F;
12) BOISE HEART PACK-LF, Pack Number CMPJ09225F;
13) VASCULAR PACK, Pack Number CMPJ09236D;
14) VASCULAR/OR ANGIO PACK, Pack Number CMPJ09236F;
15) CAROTID ENDARTERECTOMY PACK, Pack Number CMPJ09400C;
16) CAROTID PACK, Pack Number CMPJ10797B;
17) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985A;
18) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985B;
19) VASCULAR PACK, Pack Number CMPJ13632;
20) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048M;
21) CABG PACK-LF, Pack Number DYNJ0824648K;
22) HEART PEDIATRIC PACK-LF, Pack Number DYNJ16541R;
23) ADULT CARDIO TRAY, Pack Number DYNJ35495G;
24) ADULT CARDIO TRAY, Pack Number DYNJ35495G;
25) PEDIATRIC CARDIO CATH PACK, Pack Number DYNJ35578G;
26) MAJOR VASCULAR PACK, Pack Number DYNJ38318F;
27) MAJOR VASCULAR PACK, Pack Number DYNJ38318G;
28) EP PACER PACK, Pack Number DYNJ38863N;
29) EP PACER PACK, Pack Number DYNJ38863O;
30) PERFUSION SYRINGE, Pack Number DYNJ39223C;
31) VASCULAR PACK, Pack Number DYNJ39525;
32) VASCULAR ADD ON PACK, Pack Number DYNJ44420C;
33) SHUNT ENDARTERECTOMY, Pack Number DYNJ44565D;
34) VASCULAR ACCESS PACK, Pack Number DYNJ56510A;
35) HEART VALVE PACK, Pack Number DYNJ58365J;
36) RIGHT HEART PACK MOSES, Pack Number DYNJ58873A;
37) GENERAL VASCULAR PACK, Pack Number DYNJ60177A;
38) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904A;
39) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904B;
40) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904C;
41) PK, VASCULAR-MAJOR, Pack Number DYNJ61603A;
42) VASCULAR PACK, Pack Number DYNJ63182A;
43) VASCULAR SHARED, Pack Number DYNJ64801B;
44) VASCULAR PACK, Pack Number DYNJ65160;
45) VASCULAR DSC, Pack Number DYNJ69172B;
46) OPEN HEART PACK, Pack Number DYNJ83695;
47) WMC HYBRID OR, Pack Number DYNJ904036J;
48) VASCULAR, Pack Number DYNJ904845G;
49) BOISE HEART, Pack Number DYNJ905070I;
50) VASCULAR/OR ANGIO, Pack Number DYNJ905079F;
51) VASCULAR PACK, Pack Number DYNJ905226D;
52) CAROTID, Pack Number DYNJ906561F;
53) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744A;
54) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744B;
55) UNIVERSITY VASCULAR, Pack Number DYNJ907201B;
56) KIT OPEN HEART, Pack Number DYNJ908603B;
57) VASCULAR PACK, Pack Number DYNJ909374;
58) ISLET CELL UNIV OF IL, Pack Number DYNJ909768;
59) ADULT CORONARY PACK, Pack Number DYNJV0275J;
60) ADULT CORONARY PACK, Pack Number DYNJV0275K;
61) ADULT CORONARY PACK, Pack Number DYNJV0275M;
62) ADULT CORONARY PACK, Pack Number DYNJV0275N