Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F-
Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517820
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3295-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Feb 16, 2024
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa
Part Number: 84051010A
Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development
Root cause: Under Investigation by firm
Recalling firm: CooperSurgical, Inc.Type: Media, ReproductiveDistribution: Worldwide distribution - US Nationwide.Recall #Z-3296-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Feb 16, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060A
Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development
Root cause: Under Investigation by firm
Recalling firm: CooperSurgical, Inc.Type: Media, ReproductiveDistribution: Worldwide distribution - US Nationwide.Recall #Z-3297-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Feb 16, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060D
Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development
Root cause: Under Investigation by firm
Recalling firm: CooperSurgical, Inc.Type: Media, ReproductiveDistribution: Worldwide distribution - US Nationwide.Recall #Z-3298-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Jul 26, 2024
Arrow Arterial Kits and Trays as follows:
(1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;
(2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK;
(3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1;
(4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS;
(5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID;
(6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC;
(7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA;
(8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD;
(9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL;
(10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS;
(11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3;
(12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH;
(13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL;
(14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and
(15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.
Reason: Reports have been received regarding open seals on the packaging.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL Inc.Type: Wire, Guide, CatheterDistribution: US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.Recall #Z-3299-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Jan 9, 2024
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Reason: Potential for particles to be present in solution.
Root cause: Device Design
Recalling firm: Dr Franz Koehler Chemie GmbhType: Set, Perfusion, Kidney, DisposableDistribution: US Nationwide distribution in the state of North Carolina.Recall #Z-3300-2024
Open, ClassifiedPosted Sep 26, 2024·Initiated Jul 24, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;
(b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile;
(c) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888264960, Sterile; and
(d) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888264986, Sterile;
Reason: The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Root cause: Labeling Change Control
Recalling firm: Cardinal Health 200, LLCType: Tubes, Gastrointestinal (And Accessories)Distribution: Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution.
Foreign distribution was made to Chile.Recall #Z-3301-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Jul 24, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile;
(b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122, Sterile;
(c) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888266130, Sterile; and
(d) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888266148, Sterile.
Reason: The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Root cause: Labeling Change Control
Recalling firm: Cardinal Health 200, LLCType: Tube, Double Lumen For Intestinal Decompression And/Or IntubationDistribution: Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution.
Foreign distribution was made to Chile.Recall #Z-3302-2024 Open, ClassifiedPosted Sep 25, 2024·Initiated Nov 23, 2023
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Reason: When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: FUJIFILM Healthcare Americas CorporationType: System, X-Ray, MobileDistribution: US Nationwide and WorldwideRecall #Z-3158-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 19, 2024
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis
Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows
Model/Catalog Number:
1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS
2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS
3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS
4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS
5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS
6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS
7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS)
8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)
Reason: Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
Root cause: Software design
Recalling firm: Hologic IncType: Digital Breast TomosynthesisDistribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands.Recall #Z-3248-2024 Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 30, 2024
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Reason: During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
Root cause: Nonconforming Material/Component
Recalling firm: Philips North AmericaType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US Nationwide. Global Distribution.Recall #Z-3249-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G24667
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3250-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G24668
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3251-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G54612
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3252-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G54613
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3253-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G54614
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3254-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G46374
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3255-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G46372
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3256-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G46373
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3257-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46601
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3258-2024