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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Medical Action Industries Inc: Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Agency Publication Date: July 1, 2014
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Affected Products

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

Model number: 68350, Lot numbers: 187146, 187341, 187150 & 187148, Exp. Date: 12/01/2016; Model number: 58168, Lot number: 187212, Exp. Date: 11/1/2016; Model number: 68297B, Lot number: 187196, Exp. Date: 12/1/2016 and Model number: 72851B, Lot number: 187208, Exp. Date: 12/1/2018.

Lot Numbers:
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Product: Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Model number: 72347, Lot number: 187172, Exp. Date: 9/1/2015.

Lot Numbers:
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Product: Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.

Lot Numbers:
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Product: Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015.

Lot Numbers:
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Product: Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Model number: 70828, Lot number: 187176, Exp. Date: 1/1/2016.

Lot Numbers:
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Product: Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017.

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Product: McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228

Model number: 25-2685, Lot number: 187211, Exp. Date: 12/1/2016.

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

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

Lot Numbers:
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68564
Status: Resolved
Manufacturer: Medical Action Industries Inc
Manufactured In: United States
Units Affected: 8 products (474 cs (9,480 ea) total for all kits involved.; 474 cs (9,480 ea) total for all kits involved; 474 cs (9,480 ea) total for all kits involved; 474 cs (9,480 ea) total for all kits involved; 474 cs (9,480 ea) total for all kits involved; 474 cs (9,480 ea) total for all kits involved; 474 cs (9,480 ea) total for all kits involved; 474 cs (9,480 ea) total for all kits involved)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.