5 x 93 US Probe Cover CMS-6049 recall: Endotoxin
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…
Why was 5 x 93 US Probe Cover CMS-6049 recalled?
No endotoxin (LAL) testing to proper level.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Custom Medical Specialties, Inc.
- Quantity
- 2,610
- Distribution
- US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI.
- Recall date
- February 19, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)