Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Recall Z-1957-2014 · Posted 2014-07-01
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Recalling FirmMedical Action Industries Inc
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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