Reason: Potential breach of sterile barrier packaging.
Z-1886-2025June 11, 2025Mansfield, MA
Civco Medical Instruments Co. Inc.
Class IIOngoing
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Reason: During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the...
Z-1892-2025June 11, 2025Kalona, IA
Mozarc Medical US LLC
Class IIOngoing
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason: Potential breach of sterile barrier packaging.
Z-1889-2025June 11, 2025Mansfield, MA
Mozarc Medical US LLC
Class IIOngoing
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason: Potential breach of sterile barrier packaging.
Z-1885-2025June 11, 2025Mansfield, MA
Cardinal Health 200, LLC
Class IIOngoing
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1871-2025June 4, 2025Waukegan, IL
Cardinal Health 200, LLC
Class IIOngoing
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1873-2025June 4, 2025Waukegan, IL
Cardinal Health 200, LLC
Class IIOngoing
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1872-2025June 4, 2025Waukegan, IL
Cardinal Health 200, LLC
Class IIOngoing
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1870-2025June 4, 2025Waukegan, IL
Cardinal Health 200, LLC
Class IIOngoing
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1874-2025June 4, 2025Waukegan, IL
Cardinal Health 200, LLC
Class IIOngoing
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1875-2025June 4, 2025Waukegan, IL
Centerline Biomedical Inc
Class IOngoing
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Reason: Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Z-1760-2025May 28, 2025Cleveland, OH
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguar...
Reason: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the n...
Z-1808-2025May 28, 2025Sandy, UT
Numed Inc
Class IITerminated
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Reason: Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled ...
Reason: Due to a potential open seal in the sterile barrier packaging.
Z-1735-2025May 14, 2025Garland, TX
Galt Medical Corporation
Class IIOngoing
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into t...
Reason: Due to a potential open seal in the sterile barrier packaging .
Z-1732-2025May 14, 2025Garland, TX
Galt Medical Corporation
Class IIOngoing
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
Reason: Due to a potential open seal in the sterile barrier packaging .
Z-1731-2025May 14, 2025Garland, TX
Galt Medical Corporation
Class IIOngoing
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices...
Reason: Due to a potential open seal in the sterile barrier packaging.
Z-1737-2025May 14, 2025Garland, TX
Galt Medical Corporation
Class IIOngoing
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introdu...
Reason: Due to a potential open seal in the sterile barrier packaging .
Z-1733-2025May 14, 2025Garland, TX
Galt Medical Corporation
Class IIOngoing
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral va...
Reason: Due to a potential open seal in the sterile barrier packaging.