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Terminated

HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132

FDA Recall Z-0020-2011 · Posted 2010-10-07

Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeGBS
Date Initiated2010-08-10
Date Terminated2016-04-22
Product Quantity1 case, 10/case

Reason for Recall

Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.

Firm Action

Atrium Medical isued Product Recall Notice letters dated August 10, 2010 to customers, identifying the affected product and actions to be taken by customers. Customers were instructed to remove the affected products from inventory and return them to Atrium, and complete and fax a recall notice acknowledgement to Atriuim at 603-821-1420. Customers can contact Atrium at 800 528-7486, x5350 (Joe DePaolo) or x5351 (Karen Hall) for further information.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.

Official Source

View FDA Recall →

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

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