Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(803…
Atrium Medical Corporation · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Status
- Ongoing
- City
- Merrimack
- State
- NH
- Country
- United States
- Classification
- Class II
- Product type
- Devices
- Event ID
- 99680
- Recalling firm
- Atrium Medical Corporation
- Address 1
- 40 Continental Blvd
- Postal code
- 03054-4332
- Voluntary mandated
- Voluntary: Firm initiated
- Distribution pattern
- US Nationwide distribution.
- Recall number
- Z-3111-2026
- Product description
- 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);
- Product quantity
- 3618
- Reason for recall
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Recall initiation date
- 20260807
- Center classification date
- 20260904
- Report date
- 20260916
- Code info
1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;