Z-1032-2015Class II

HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose...

Name: Z-1032-2015 HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose...
Creator: Fresenius Kabi USA, LLC
Published: 2014-12-19
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2014-12-19 / Terminated / root cause: design

FDA source

Fresenius Kabi USA, LLC began a recall of 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... on 2014-12-19. FDA classified it as Class II and gives the reason as "The lot failed pH specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1032-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-01-29
Terminated: 2016-01-26
Recalling firm: Fresenius Kabi USA, LLC
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
Product code: NZW Heparin, Vascular Access Flush
Reason for recall: The lot failed pH specification.
Root cause tag: design
FDA root cause: Component design/selection
Action: Fresenius sent an URGENT DRUG RECALL Letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Examine their stock immediately to determine if they have any product from the affected lot. If the consignee is a distributor, immediately notify your customers that have been shipped or may have been shipped this product/lot of this recall and direct them to discontinue distributing or dispensing the affected lot. Please have them prepare to return the product to Fresenius Kabi as instructed in the Urgent Product Recall Response Form. Your customers may retrieve the recall letter and response form at http://www.fresenius-kabi.us /products/pharmaceutical-products/product-updates.html. 2. If you have the affected lot available, immediately discontinue distributing or dispensing the lot, and return all units to Fresenius Kabi ,via FedEx Ground, using the enclosed return goods label and packing slip. A FedEx Ground label can be obtained by checking the box and noting your mailing address on the enclosed Urgent Product Recall Response Form. It will be mailed to the consignee upon receiving the request. A credit memo will be issued covering the quantity of the return to Fresenius Kabi. 3. PLEASE COMPLETE THE ENCLOSED "URGENT PRODUCT RECALL RESPONSE FORM" AND SEND IT BACK TO US IMMEDIATELY VIA EMAIL OR FAX AT 1-708-649-8630. Use the following contact phone numbers as appropriate. Hours of operation: Monday through Friday 8:00 am to 5:00 pm CST: QA Department: (866) 716-2459 for information on how to return product; Vigilance & Medical Affairs: 1(800) 551-7176 for clinical/technical information/Adverse Events (ADE's) reporting.
Quantity in commerce: Domestic: 69,725
Distribution: Nationwide Distribution
Product codes and lots: Lot 6005501, Exp. Date 1/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1032-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1032-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-29

Product code NZW

K092938Class IIHeparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710App Pharmaceuticals, LLC / cleared 2010-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)