FDA Recalls 9,489 Surgical Instrument Kits for Recalled 3M Drapes
Windstone Medical Packaging is recalling 9,489 custom surgical instrument kits that contain 3M Steri-Drape Surgical Drapes, which have been recalled by 3M Healthcare. Kits were distributed worldwide and in multiple U.S. states.
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: This is an FDA Class II recall of surgical instrument kits containing a recalled component. No illnesses or injuries are reported. The score reflects the risk-of-harm nature of surgical medical devices combined with the absence of reported harm.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 9,489 custom surgical instrument disposable kits because the kits contain 3M Steri-Drape Surgical Drapes that 3M Healthcare has recalled. These kits are designed for various surgical procedures and include multiple product types identified by specific part numbers and UDI codes.
The recalled kits were distributed worldwide and to multiple U.S. states including Arizona, California, Colorado, Connecticut, Florida, Guam, Indiana, North Carolina, New Jersey, Nevada, Oklahoma, Pennsylvania, Tennessee, Texas, and Wisconsin, as well as to Canada.
The recalled product
- Product
- Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack…
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 9,489
Distribution
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