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

Safety Laceration Kit, Sterile Single Use, Latex Free recalled

Medical Action Industries is recalling Safety Laceration Kit, 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: 59108B, Lot number: 187210, Exp. Date: 2/1/2017.

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-1955-2014
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
Device type: Other Medical Devices

Timeline

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

Safety Laceration Kit, 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.

Arkansas Arizona Florida Georgia Iowa Illinois Kentucky Massachusetts Minnesota North Carolina New York Ohio Tennessee Texas Virginia

Questions about this recall

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

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.

Other products in this recall event

7 other products · FDA event 68564

This product is part of a recall event; the main page for the event is Suture Set, Sterile Single Use, Stage recalled.

Reported	Class	Recall	Company	Reason	Where
9 Jul 2014	CLASS II	Suture Set, Sterile Single Use, Stage recalled	Medical Action Industries	Sterility	15 states
9 Jul 2014	CLASS II	Max Barrier Kit, Sterile Single Use, Latex Free recalled	Medical Action Industries	Sterility	15 states
9 Jul 2014	CLASS II	Laceration/Suture Removal, Sterile Single Use, Latex Free recalled	Medical Action Industries	Sterility	15 states
9 Jul 2014	CLASS II	Laceration Trays, Sterile Single Use, Latex Free recalled	Medical Action Industries	Sterility	15 states
9 Jul 2014	CLASS II	Laceration Kit: W/Needles, Sterile Single Use, Latex Free recalled	Medical Action Industries	Sterility	15 states
9 Jul 2014	CLASS II	Port-A-Cath Tray, Stage One: Sterile Single Use, Stage recalled	Medical Action Industries	Sterility	15 states
9 Jul 2014	CLASS II	McKesson Medi-Pak, Laceration Trays with Cotton O.R recalled	Medical Action Industries	Sterility	15 states

More recalls from Medical Action Industries

All 14

Reported	Class	Recall	Company	Reason	Where
3 Apr 2019Device	CLASS II	Laparotomy Sponge with the following product description recalled	Medical Action Industries	Sterility	Nationwide
2 Jan 2019Device	CLASS II	Laparotomy Sponge, XR No Loop, Single-Use, Sterile recalled	Medical Action Industries	Sterility	5 states
6 Jun 2018Device	CLASS II	Blue OR Towel Non X-Ray Detectable recalled by Medical Action Industries	Medical Action Industries	Sterility	Nationwide
24 May 2017Device	CLASS II	Blue OR Towels, X-Ray Detectable, Sterile recalled	Medical Action Industries	Sterility	AR, IN, NV
24 May 2017Device	CLASS II	White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk;/Cs recalled	Medical Action Industries	Sterility	AR, IN, NV

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All 13,778

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16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide