Recall Z-0974-2014— Custom Medical Specialties, Inc.

Name: FDA recall Z-0974-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-12

Class II · Terminated

Class II FDA medical device recall by Custom Medical Specialties, Inc., initiated 2013-07-12, terminated 2014-04-08. It names one FDA 510(k) clearance: K882724. 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..

Recalling firm: Custom Medical Specialties, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-12
Terminated: 2014-04-08
Firm location: Pine Level, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K882724 — MICROTEK PROBE DRAPEMicrobio-Medics, Inc.·cleared 1988-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

No endotoxin (LAL) testing to proper level.

Data sourced from openFDA. This site is unofficial and independent of the FDA.