Z-0974-2014Class II

5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level...

Name: Z-0974-2014 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level...
Creator: Custom Medical Specialties, Inc.
Published: 2013-07-12
License: https://open.fda.gov/license/

Custom Medical Specialties, Inc. / initiated 2013-07-12 / Terminated / root cause: sterility

FDA source

Custom Medical Specialties, Inc. began a recall of 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the... on 2013-07-12. FDA classified it as Class II and gives the reason as "No endotoxin (LAL) testing to proper level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0974-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-12
Posted: 2014-02-12
Terminated: 2014-04-08
Recalling firm: Custom Medical Specialties, Inc.
Product: 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: No endotoxin (LAL) testing to proper level.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Microtek - Ecolab sent a Urgent Medical Device Recall Letter dated July 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you purchased this product CMS-6049 and this recall is dating back as far was 2008. Attached is a list affected lot number, however, all lots of the CMS-6049 are being recalled. Please inspect your inventory and return any product to us. To prevent any potential patient harm, discontinue the use of the probe cover. In order to advise the Food and Drug Administration about the effectiveness of this recall, you are requested to complete and return the enclosed questionnaire promptly fax or email it no later than July 29, 2013. It is necessary to report to us even if all products have been used. Any product still in your inventory is to be returned to us using a Return Authorization Number and our shipping number which will be given to you by calling (919) 202-8462Ext. 205.
Quantity in commerce: 2,610
Distribution: US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI.
Product codes and lots: Microtek/Ecolab Lot Nos. D91821, D92081, D92301, D93411, D100891, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521 - Custom Medical Lot Nos. 15831-0906, Exp. 6/2012; 17181-0910, Exp. 1/2012; 17926-1001, Exp. 1/2013; 18672-1003, Exp. 3/2013; 19067-104, Exp. 4/2013; 19683-1005, Exp. 5/2013; 19771-1006, Exp. 6/2013; 19931-1006, Exp. 6/2013; 21886-1010, Exp. 10/2013; 23233-1103, Exp. 3/2014; 24926-1108, Exp. 8/2014; 25201-1109, Exp. 9/2014; 26150-1112, Exp. 12/2014; 26502-1201, Exp. 1/2015; 27522-1204, Exp. 4/2015; 28161-1206, Exp. 6/2015; 28999-1208, Exp. 8/2015; 29153-1208, Exp. 8/2015; 31811-1304, Exp. 4/2016; 32056-1305, Exp. 5/2016; 32391-1306, Exp. 6/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0974-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0974-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-12

Product code KKX

K882724Class IIMicrotek Probe DrapeMicrobio-Medics, Inc. / cleared 1988-08-03

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)