Recalls / —

—#93863

Product

HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124

FDA product code

GBS — Catheter, Ventricular, General & Plastic Surgery

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot 10633072

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm

Atrium Medical Corporation

Address

5 Wentworth Dr, Hudson, New Hampshire 03051

Distribution

Distribution pattern

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

Timeline

Recall initiated

2010-08-10

Posted by FDA

2010-10-07

Terminated

2016-04-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #93863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.