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Recall Observatory FDA recall evidence

Device product

1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

Z-2742-2018

February 02, 2018

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 80650
Status
Terminated
Classification
Class II
Quantity
22,234
Official record key
device-enforcement:Z-2742-2018

Official wording

Reason: Supplier manufacturing defect with the syringe plunger tip.

Code information: 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.

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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect