Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
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-3113-2026
- Product description
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Product quantity
- 256
- 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): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;