Atrium Medical Corporation: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 Per Case; Size(model Number): 1. 16fr(8016), 2. 24fr(8024), 3. 28fr(8028), 4. 32fr(8032), 5. 3...
Recall Summary Atrium Medical Corporation is recalling one lot of Getinge PVC Thoracic Catheters (available in sizes 16FR, 24FR, 28FR, 32FR, and 36FR) distributed nationwide because testing found bacterial endotoxin levels that exceeded acceptable limits. This is a Class II recall, meaning the catheters could potentially cause serious health problems or temporary adverse health effects. The affected catheters were distributed across all U.S. states and the District of Columbia.
- Recalling firm
- Atrium Medical Corporation
- Product
- Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
- Reason
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-07
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/37bd5528-85ac-4af0-add3-1529d14c400e