Reported Feb 19, 2014 · Terminated

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

Custom Medical Specialties, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Custom Medical Specialties, Inc. · 330 East Main Street · Pine Level, NC · 27568

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

Lot codes and dates: 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
Amount recalled: 2,610

No endotoxin (LAL) testing to proper level.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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