Z-0285-2007
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr...
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. 6 Fr. Introducer Kit. Ref Product No. AP-06014 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-0285-2007
- 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. 6 Fr. Introducer Kit. Ref Product No. AP-06014
- 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
- 94
- Distribution
- Nationwide. The firm is NOT recalling from international accounts.
- Product codes and lots
- Product No. AP-06014. Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186,MF3116232, MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653, MF5049105,MF5050037, MF5092675, MF5103680, MF6014995, MF6079156, MF6089978.
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