1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
FDA Recall Z-2742-2018 · Posted None
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2018-02-02
Date Terminated2020-11-30
Product Quantity22,234
Reason for Recall
Supplier manufacturing defect with the syringe plunger tip.
Firm Action
On February 2, 2018 Merit Medical sent a "URGENT PRODUCT RECALL NOTICE" letter to all their consignees requesting the following actions;
Actions required of you:
1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution.
2. Ensure that applicable personnel within your organization are made aware of this field action.
3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities.
4. Please fill out, scan and email the completed CRF to Merit Customer Service at [email protected] or fax at 801.316.4880 within 10 days.
5. Please immediately return all affected lots in your possession to Merit, per the instructions found in the CRF.
If you have any questions concerning this communication, please dont hesitate to contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, ME, MI, MN, MO, NC, ND, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TB, TN, TX, UT, VA, WI, and WV; and countries of; Canada, Colombia, France, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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