Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
Reason: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to th...
Z-0648-2024January 17, 2024Danvers, MA
Merit Medical Systems, Inc.
Class IIOngoing
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Reason: The sterility of microcatheter and infusion system devices cannot be guaranteed.
Reason: The sterility of microcatheter and infusion system devices cannot be guaranteed.
Z-0627-2024January 10, 2024South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Reason: The sterility of microcatheter and infusion system devices cannot be guaranteed.
Z-0629-2024January 10, 2024South Jordan, UT
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; ...
Reason: The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of t...
Reason: Incorrect product labeling. Exterior product box label does not match internal pouch label.
Z-0509-2024December 20, 2023Colorado Springs, CO
Medtronic Inc.
Class IICompleted
Medtronic SynchroMed, Model A10
Reason: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Cath...
Z-0522-2024December 20, 2023Mounds View, MN
C.R. Bard Inc
Class IIOngoing
Sensica Urine Output System, Catalog Number SCCS1002
Reason: BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitor...
Z-0554-2024December 20, 2023Covington, GA
CooperSurgical, Inc.
Class IIOngoing
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology s...
Reason: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay...
Z-0504-2024December 13, 2023Trumbull, CT
CooperSurgical, Inc.
Class IIOngoing
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesio...
Reason: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay...
Z-0502-2024December 13, 2023Trumbull, CT
CooperSurgical, Inc.
Class IIOngoing
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhe...
Reason: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay...
Z-0503-2024December 13, 2023Trumbull, CT
Atrium Medical Corporation
Class IIOngoing
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reason: A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Z-0484-2024December 13, 2023Merrimack, NH
Becton Dickinson Infusion Therapy Systems Inc.
Class IIOngoing
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Reason: Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from th...
Z-0400-2024December 6, 2023Sandy, UT
Atrium Medical Corporation
Class IIOngoing
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter A...
Reason: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Reason: Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube...
Z-0318-2024November 22, 2023Merrimack, NH
Atrium Medical Corporation
Class IIOngoing
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
Reason: Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube...
Z-0317-2024November 22, 2023Merrimack, NH
Atrium Medical Corporation
Class IIOngoing
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/...
Reason: Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube...
Z-0316-2024November 22, 2023Merrimack, NH
ROi CPS LLC
Class IIOngoing
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reason: Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution i...
Reason: Non-sterile product labeled as sterile was distributed.
Z-0286-2024November 15, 2023Miami Lakes, FL
Access Vascular, Inc
Class IIOngoing
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Reason: Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: Hy...
Z-0115-2024October 25, 2023Billerica, MA
Access Vascular, Inc
Class IIOngoing
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Reason: Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: Hy...
Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a...
Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a...