Kimberly-Clark Recalls Non-Commercial Sterile Surgical Gowns
Kimberly-Clark is recalling 32 cases of sterile surgical gowns that were not intended for commercial distribution to end users.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and the product was not intended for commercial distribution.
Plain-English summary
Kimberly-Clark Corporation is recalling 32 cases of ULTRA Fabric Reinforced Surgical Gowns, size X-Large, sterile. The product is a single-use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The recall was initiated because the impacted product was not intended for commercial distribution to end users. The affected units are identified by Product Code 95221-35 and Unit Code 90372.
The recall covers distribution in the United States, including the states of California, Colorado, Louisiana, New Mexico, Oklahoma, Texas, and Washington. Because the product was not intended for commercial distribution, no specific consumer action is required for the general public.
The recalled product
- Product
- ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body…
- Manufacturer
- Kimberly-Clark Corporation
- Category
- Medical Device — Surgical Gowns
- Hazard
- Affected units
- 32
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 (2)
- Product Code: 95221-35
- Unit Code: 90372
Distribution
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