—#30602

Product

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).

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K921475, K933316, K934802, K960200
Affected lot / code info: AP-06022 MF3075080 MF3085227 MF3085410

Why it was recalled

The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.

Root cause (FDA determination)

Other

Action the firm took

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').

Recalling firm

Firm: Arrow International Inc
Address: 2 Berry Dr, Mount Holly, New Jersey 08060-5017

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-11-04
Posted by FDA: 2004-07-20
Terminated: 2004-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.