Z-0503-2011

VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah...

Name: Z-0503-2011 VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah...
Creator: Merit Medical Systems, Inc.
Published: 2010-10-22
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-10-22 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095 on 2010-10-22. The reason FDA records is "Packaging for syringes may have holes which would compromise the sterility of the package contents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0503-2011
Status: Terminated
Initiated: 2010-10-22
Posted: 2010-12-02
Terminated: 2011-01-18
Recalling firm: Merit Medical Systems, Inc.
Product: VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Product code: FMF Syringe, Piston
Reason for recall: Packaging for syringes may have holes which would compromise the sterility of the package contents.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Merit Medical notified product managers of the product recall on October 22, 2010 following a voice mail script. Frequently Asked Questions, Sales Rep Letter, and Recall Notification Forms were then sent.. Sales reps were instructed to contact all of their customers and have them identify and quarantine any unused inventory and either return it to Merit or discard. A response form was to completed by the sales rep and the firm's representative, indicating amount of product quarantined, returned , or destroyed. Also, on 10/22/2010, authorized distributors were contacted by phone, mail, and / or fax. They were also provided a Distributor Letter, FAQs, and Recall Notification Forms instructing them to identify and quarantine any unused inventory and return it to Merit or discard. They were instructed to continue the recall to customers to whom they had shipped the affected Merit product. Additional information is available from Merit at 801-316-4822.
Quantity in commerce: 49 units
Distribution: Worldwide Distribution: USA including the states of AL, CA, GA, OH, PA, TX, UT, and WA, and to the countires of Japan and UK.
Product codes and lots: Lot Number: H168038

Product code FMF

K994253Class IIVaclok SyringeMerit Medical Systems, Inc. / cleared 2000-01-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)