Z-0272-2007
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 17...
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(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535 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-0272-2007
- 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(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535
- 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
- 89
- Distribution
- Nationwide. The firm is NOT recalling from international accounts.
- Product codes and lots
- Product No. AP-06535. Lot Numbers: MF3023376, MF3044179, MF3085273, MF3126313, MF4020636, MF6014780, MF6025930, MF6079639, MR2070141.
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.
