Z-1957-2014Class II

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

Name: Z-1957-2014 Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC
Creator: Medical Action Industries Inc
Published: 2014-06-12
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2014-06-12 / Terminated / root cause: manufacturing process

FDA source

Medical Action Industries Inc began a recall of Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC on 2014-06-12. FDA classified it as Class II and gives the reason as "Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1957-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-12
Posted: 2014-07-01
Terminated: 2015-02-03
Recalling firm: Medical Action Industries, Inc. 306
Product: Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Product code: OVN Suture Kit
Reason for recall: Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.
Quantity in commerce: 474 cs (9,480 ea) total for all kits involved
Distribution: Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Product codes and lots: Model number: 68718, Lot number: 187198, Exp. Date: 12/1/2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1950-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1951-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1952-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1953-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1954-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1955-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1956-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1957-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

Product code OVN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)