Device product
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Z-1468-2021
Product summary
- Event
- Event 87538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2970 units
- Official record key
device-enforcement:Z-1468-2021
Official wording
Reason: Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Code information: Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
Distribution pattern: US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
Derived failure modes
-
Sterility assurance
compromised sterility