Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO… recallZ-0506-2011 · Merit Medical Systems, Inc. · initiated Oct 22, 2010
Terminated All recalls posted in December 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Packaging for syringes may have holes which would compromise the sterility of the package contents.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0506-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 22, 2010
- Posted by the FDA
- Dec 2, 2010
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 25 units
- Product code
- FMF
- FDA submissions
- K994253
- 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 description
Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Code information (models, lots, serial numbers)
Lot Number: H166677
Other devices under the same FDA submission
1 device cleared under K994253 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Syringe Kit - Stroke MVSK60Microvention, Inc. · Syringe, piston1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 57102).
- Z-0503-2011 · TerminatedVACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Z-0504-2011 · TerminatedVACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Z-0505-2011 · TerminatedMerit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page