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(803
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-08-07
- 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;
- Product quantity
- 3618
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Merrimack
- State
- NH
- Country
- United States
- Event id
- 99680
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