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Class 2 Device Recall 5 x 93 US Probe Cover CMS6049 |
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Date Initiated by Firm |
July 12, 2013 |
Date Posted |
February 12, 2014 |
Recall Status1 |
Terminated 3 on April 08, 2014 |
Recall Number |
Z-0974-2014 |
Recall Event ID |
65753 |
510(K)Number |
K882724
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Product Classification |
Drape Surgical - Product Code KKX
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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 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Custom Medical Specialties, Inc. 330 East Main Street Pine Level NC 27568
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For Additional Information Contact |
Diane McAlinn 919-202-8462 Ext. 250
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Manufacturer Reason for Recall |
No endotoxin (LAL) testing to proper level.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KKX and Original Applicant = MICROBIO-MEDICS, INC.
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