Z-1995-2021 Class II Terminated

Recalled by CAREFUSION — San Diego, CA

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