HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
FDA device recall Z-0019-2011 · posted 2010-10-07 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters.
- Action taken
- 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
- Status
- Terminated
- Product code
- GBS
- Quantity affected
- 10 cases, 10/case
- Distribution
- Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.
- Date initiated
- 2010-08-10
- Date posted
- 2010-10-07
- Date terminated
- 2016-04-22
- Location
- Hudson, NH
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