Z-0019-2011

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

Name: Z-0019-2011 HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Creator: Atrium Medical Corporation
Published: 2010-08-10
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2010-08-10 / Terminated / root cause: packaging

FDA source

Atrium Medical Corporation began a recall of HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124 on 2010-08-10. The reason FDA records is "Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0019-2011
Status: Terminated
Initiated: 2010-08-10
Posted: 2010-10-07
Terminated: 2016-04-22
Recalling firm: Atrium Medical Corporation
Product: HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Product code: GBS Catheter, Ventricular, General & Plastic Surgery
Reason for recall: Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 10 cases, 10/case
Distribution: Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.
Product codes and lots: Lot 10633072

Product code GBS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)