Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing
Custom Medical Specialties is recalling 2,610 sterile ultrasound probe covers because they were not tested for endotoxins to the required level.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a sterile medical device lacking required endotoxin testing, which poses a risk of harm (sepsis) even though specific injuries are not reported in the source text.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 2,610 units of the 5 x 93 US Probe Cover CMS-6049. These sterile, single-patient-use probe covers are restricted by federal law to sale by or on the order of a physician. The recall is being conducted because the product did not undergo endotoxin (LAL) testing to the proper level.
The affected units were distributed across the United States, specifically in the states of Connecticut, Florida, Illinois, New Jersey, New York, Pennsylvania, Tennessee, Virginia, and Wisconsin. The recall includes specific Microtek/Ecolab lot numbers and Custom Medical lot numbers with expiration dates ranging from January 2012 to June 2016.
Healthcare facilities and consumers should stop using these probe covers and contact Custom Medical Specialties, Inc. for further instructions on the recall.
The recalled product
- 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
- Manufacturer
- Custom Medical Specialties, Inc.
- Affected units
- 2,610
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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