FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Recall number
- Z-0504-2011
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Status
- Terminated
- Initiated
- 2010-10-22
- Posted
- 2010-12-02
- Terminated
- 2011-01-18
- Reason
- Packaging for syringes may have holes which would compromise the sterility of the package contents.
- 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
- 789 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.
- Lot, serial or model codes
- Lot Number: H162820
- 510(k) numbers
- ["K994253"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28