Recall Z-3112-2026
- Recall number
- Z-3112-2026
- Event number
- 99680
- Firm
- Atrium Medical Corporation
- Firm FEI
- 3011175548
- Product code
- GBZ
- Status
- Open, Classified
- Initiated
- 2026-08-07
- Posted
- 2026-09-04
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K895285, K901520, K924128, K925742, K830711, K926143, K772288, K973621, K860534, K833059, K932228, K942450, K914015, K924212, K944790, K921091, K920643, K924480, K924981, K873471, K903709, K831931, K926217, K870420
Product#
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);
Reason for Recall#
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.