Ecolab Recalls Microtek ORS Fluid Warming and Slush Drapes Due to Seal Defects
Ecolab is recalling Microtek ORS Fluid Warming and Slush Drapes because sterile packaging seals may contain small channels, potentially compromising package integrity and sterility.
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 involves a risk-of-harm product (sterile surgical drapes) where the hazard is the potential use of non-sterile items during surgery, but the source text describes the chance as 'remote' and does not report any illnesses or injuries.
Plain-English summary
Ecolab Inc is recalling Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, including models ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331, and ORS-2200. The affected products are individually wrapped in poly-Tyvek pouches and packaged in corrugated shipper boxes. A total of 5,172,816 units are subject to this recall.
The recall is due to a defect in the sterile packaging where the seal of the pouch may contain small channels less than 250 microns wide. If these channels are present, the package integrity is compromised, creating a remote chance that a non-sterile drape may be used during a surgical procedure. The drapes are intended for use during various surgeries where warm irrigation, slush, or cold solution are required.
The affected products were distributed worldwide, including the United States (including DC and PR), Saudi Arabia, Lebanon, Germany, Hong Kong, Singapore, Canada, and Japan. Healthcare facilities and distributors should check their inventory for the specific lot codes listed in the official recall notice and stop using the affected products immediately.
The recalled product
- Product
- Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with…
- Manufacturer
- Ecolab Inc
- Category
- Medical Device — Surgical Drapes
- Affected units
- 5,172,816
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)
- ORS Fluid Warming Drape
- 44" x 44" SKU # ORS-100: D112392
- D112412
- D112412A
- D112921
- D112932
- D112942
- D112972
- D112972A
- D112982
- D112992
- D113002
- D113002A
- D113012
- D113022
- D113042
- D113052
- D113052A
- D113062
- D113072
Distribution
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