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Recall Observatory FDA recall evidence

Device product

Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Z-1957-2014

June 12, 2014

Class II

Product summary

Firm
Medical Action Industries Inc
Event
Event 68564
Status
Terminated
Classification
Class II
Quantity
474 cs (9,480 ea) total for all kits involved
Official record key
device-enforcement:Z-1957-2014

Official wording

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

Code information: Model number: 68718, Lot number: 187198, Exp. Date: 12/1/2016.

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile kits may have incomplete seals which might compromise