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Terminated

Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.

FDA Recall Z-1950-2014 · Posted 2014-07-01

Recall StatusTerminated
Product CodeOVN
Date Initiated2014-06-12
Date Terminated2015-02-03
Product Quantity474 cs (9,480 ea) total for all kits involved.

Reason for Recall

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Firm Action

Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

Official Source

View FDA Recall →

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

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