Z-1995-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- June 9, 2021
- Termination Date
- July 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Reason for Recall
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Distribution Pattern
U.S.: TN O.U.S.: None
Code Information
Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194