CAREFUSION: Medical Device Recall in 2021 - (Recall #: Z-1995-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 9, 2021

Date Posted: July 7, 2021

Recall Number: Z-1995-2021

Event ID: 88104

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.

Status: Terminated

Product Quantity: 100 units

Code Information:

Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated