Recall Z-1032-2015— Fresenius Kabi USA, LLC

Name: FDA recall Z-1032-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2014-12-19, terminated 2016-01-26. It names one FDA 510(k) clearance: K092938. Product: 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. Reason: The lot failed pH specification..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2016-01-26
Firm location: Lake Zurich, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K092938 — HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710App Pharmaceuticals, LLC·cleared 2010-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

The lot failed pH specification.

Data sourced from openFDA. This site is unofficial and independent of the FDA.