Medical Device Recall: Z-0019-2011

FDA Recalls dataset · Firm: Atrium Medical Corporation · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-08-10 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2011.

Recall Res Number
Z-0019-2011
Recalling Firm / Manufacturer
Atrium Medical Corporation
FEI Number
3011175548
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-08-10
Date Posted
2010-10-07
Date Terminated
2016-04-22
Product Code
GBS
Event Number
56536
Product Quantity
10 cases, 10/case
Product Description HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Reason for Recall Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters.
Action Details 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.
Distribution Pattern Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.
Code Information / Serial Numbers Lot 10633072

Related Establishments / Registrations

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