FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510) . Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm) straight non-coring needle, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
- Recall number
- Z-0255-04
- Recalling firm
- Arrow International Inc
- Product
- Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510) . Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm) straight non-coring needle, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
- Status
- Terminated
- Initiated
- 2003-11-04
- Posted
- 2004-07-20
- Terminated
- 2004-11-12
- Reason
- The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
- Root cause
- Other
- Action
- 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').
- Quantity
- 913
- 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, serial or model codes
- AP-01510 MF3085292 MF3085315 MF3095551 MF3095651
- 510(k) numbers
- ["K921475","K933316","K934802","K960200"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3010532612
- Firm city
- Mount Holly
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28