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Terminated

1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.

FDA Recall Z-1889-2017 · Posted None

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2017-03-23
Date Terminated2017-09-26
Product Quantity23,032 units

Reason for Recall

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

Firm Action

Consignees began receiving notification via letter on March 23, 2017 to immediately stop using or distributing the affected lots and return them back to Merit. If there are any questions, contact Merit Customer Service at (801) 208-4381.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide and other foreign consignees. No VA/govt/military or VA consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CCMerit Medical Systems, Inc. · 1988-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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