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Terminated

HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9032, Size (Fr) 32, # Eyelets 6, 10 per case

FDA Recall Z-1835-2008 · Posted 2008-08-14

Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeGBS
Date Initiated2008-05-12
Date Terminated2009-08-20
Product Quantity370 cases (10 individual/case)

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp. · 1991-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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