—#70885

Product

HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets, Increased Length by 6", Atrium Code # 14720, Size 20, # Eyelets 15, 10 per case

FDA product code: GBZ — Catheter, Cholangiography
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot #s 10307011, 10311261, 10318740, 10327154, 10336322, 10336532

Why it was recalled

Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice.

Recalling firm

Firm: Atrium Medical Corporation
Address: 5 Wentworth Dr, Hudson, New Hampshire 03051-4929

Distribution

Distribution pattern: Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.

Timeline

Recall initiated: 2008-05-12
Posted by FDA: 2008-08-14
Terminated: 2009-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70885. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.