Z-0287-2007
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2006-09-29 / Terminated
Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510 on . The reason FDA records is "Catheter has separated from the infusion port body". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0287-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510
- Product code
- LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
- Reason for recall
- Catheter has separated from the infusion port body.
- FDA root cause
- Other
- Action
- The recall notification was sent out to their US customers on 9/29/2006.
- Quantity in commerce
- 204
- Distribution
- Nationwide. The firm is NOT recalling from international accounts.
- Product codes and lots
- Product No. AP-01510. Lot Numbers: MF2061389, MF2071761, MF2082058, MF2122799,MF2122869, MF3013124, MF3023533, MF3033713, MF3044092, MF3044143, MF3054233, MF3054527,MF3064662, MF3064871, MF3085292, MF3085315, MF3095651, MF3116183, MF3116212, MF3126476, MF4016721, MF4020469, MF4020739, MF4105255, MF5017539, MF5081888, MF6068638, MS3110153,MS4041605, MS4041616, MS4041617,MS4041618.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
