—#70867

Product

HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case

FDA product code: GBS — Catheter, Ventricular, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K912645
Affected lot / code info: Lot #s 10289970, 10311123, 10311257, 10327131

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 #70867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.