FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
- Recall number
- Z-0020-2011
- Recalling firm
- Atrium Medical Corporation
- Product
- HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
- Status
- Terminated
- Initiated
- 2010-08-10
- Posted
- 2010-10-07
- Terminated
- 2016-04-22
- Reason
- Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.
- 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
- 1 case, 10/case
- Distribution
- Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.
- Lot, serial or model codes
- Lot 10636876
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GBS
- Firm FEI
- 3011175548
- Firm city
- Hudson
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28