Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB: plastic port] Product # AP-06022 kit contains 1 low profile implantable plastic port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
This recall has been terminated (originally issued July 20, 2004).
- Company
- Arrow International Inc
- Recall Initiated
- November 4, 2003
- Posted
- July 20, 2004
- Terminated
- November 12, 2004
- Recall Number
- Z-0257-04
- Quantity
- 913
- Firm Location
- Mount Holly, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
Distribution
Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.
Lot / Code Info
AP-06022 MF3075080 MF3085227 MF3085410
Root Cause
Other
Action Taken
The firm began notification of consignees via U.S. mail on 11/4/03. A notice of the recall was also posted on the firm''s website (search for 'recall').