CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report

Laceration/Suture Removal, Sterile Single Use, Latex Free recalled

Medical Action Industries is recalling Laceration/Suture Removal, Sterile Single Use, Latex Free, Medical Action Industries, Inc, distributed in 15 states. The recall was initiated on 12 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number: 72347, Lot number: 187172, Exp. Date: 9/1/2015.
Quantity recalled474 cs (9,480 ea) total for all kits involved

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1951-2014
FDA event ID
68564
Recalling firm
Medical Action Industries, Arden, NC
Classification
Class II
Status
Terminated
Recall initiated
12 Jun 2014
FDA classified
1 Jul 2014
Reported
9 Jul 2014
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Sterility

Timeline

12 Jun 2014Recall initiated by company
1 Jul 2014Classified by FDA+19 days
9 Jul 2014Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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

ArkansasArizonaFloridaGeorgiaIowaIllinoisKentuckyMassachusettsMinnesotaNorth CarolinaNew YorkOhioTennesseeTexasVirginia

Questions about this recall

Is Laceration/Suture Removal, Sterile Single Use, Latex Free, Medical Action Industries, Inc recalled?

Yes. Medical Action Industries recalled Laceration/Suture Removal, Sterile Single Use, Latex Free, Medical Action Industries, Inc on 12 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-1951-2014.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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