Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(…
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-3112-2026
- Product description
- Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
- Product quantity
- 2533
- 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): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;