FDA Device recall Z-0974-2014
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use
- FDA Device
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use by Custom Medical Specialties, citing no endotoxin (LAL) testing to proper level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0974-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-12 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Custom Medical Specialties |
| Distribution | CT, FL, IL, NJ, NY, PA, TN, VA, WI |
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
Reason
No endotoxin (LAL) testing to proper level.
Identifiers
| code_info | Microtek/Ecolab Lot Nos. D91821, D92081, D92301, D93411, D100891, D101981, D102461, D103081, D103081A, D103331, D110871…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0974-2014%22
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