Fresenius Kabi USA, LLC: Medical Device Recall in 2015 - (Recall #: Z-1032-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710

Product Classification:

Class II

Date Initiated: December 19, 2014

Date Posted: February 4, 2015

Recall Number: Z-1032-2015

Event ID: 70050

Reason for Recall:

The lot failed pH specification.

Status: Terminated

Product Quantity: Domestic: 69,725

Code Information:

Lot 6005501, Exp. Date 1/2016

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated