FDA recall Z-1995-2021

Product

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

U.S.: TN O.U.S.: None

Key facts

Status

Terminated

Initiation date

2021-06-09

Report date

2021-07-07

Termination date

2024-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1995-2021