FDAClass IIMay 3, 2017

1 mL Medallion¿ Syringe recall

1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP…

Why was 1 mL Medallion¿ Syringe recalled?

Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: B617173, H1082598, H1082648, H1082649, H1082809, H1085511, H1085645, H1092907, H1085649, H1097018, H1085658, H1085659, H1085735, H1089234, H1089419, H1090184, H1101188, H1101443.

Product
1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP…
Recalling firm
Merit Medical Systems, Inc.
Quantity
23,032 units
Distribution
Nationwide and other foreign consignees. No VA/govt/military or VA consignees.
Recall date
May 3, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls