Recalls / —
—#166073
Product
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
- FDA product code
- FMF — Syringe, Piston
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K173601
- Affected lot / code info
- Catalog Number: Lot Number: K01-05526P H1258821, K01-07427 H1263015, K01-07477P H1250809 and H1242962, K01-07930P H1246733, MSS011-DG H1246809, K02-00565C H1258361, MSS011-LG H1246810, K02-01260B H1258575 and H1265248, MSS011-PR H1242752, MSS011-R H1242754 and H1255507, K02-01331A H1252652, K04-00748 H1258488 and H1264381, MSS011-Y H1246811, MSS011-YP H1242927, K12-03636 H1258530, and MSS011 H1242750, H1246807 and H1255504.
Why it was recalled
Supplier manufacturing defect with the syringe plunger tip.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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 response@merit.com 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.
Recalling firm
- Firm
- Merit Medical Systems, Inc.
- Address
- 1600 W Merit Pkwy South, Jordan, Utah 84095-2416
Distribution
- 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.
Timeline
- Recall initiated
- 2018-02-02
- Terminated
- 2020-11-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #166073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.