Surgical Smoke Evacuation Prefilters Recalled Due to Temperature Exposure
Cooper Surgical PREFILTER, SMOKE EVAC prefilters are recalled because they were exposed to higher temperatures during storage from June through August 2021. This exposure may have reduced the product's effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is theoretical—temperature exposure may have impacted product effectiveness—with no evidence of actual patient harm. Class III recalls are typically scored 1 or 2; the medical device context warrants a Moderate score.
Plain-English summary
Cooper Surgical PREFILTER, SMOKE EVAC (Model 52560) prefilters are being recalled due to potential temperature damage during storage and transportation. The product was exposed to higher temperatures between June and August 2021 prior to delivery.
The recall affects all lots of this prefilter product received between June 1, 2021 and September 30, 2021. These prefilters are used in surgical settings for smoke evacuation. Temperature exposure during this period may have compromised the product's effectiveness.
Healthcare facilities and surgical centers that received affected lots should discontinue use and contact Mckesson Medical-Surgical Inc. for guidance on replacement or proper disposal of the recalled prefilters.
The recalled product
- Product
- Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- device-effectiveness
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 (3)
- GTIN: 20845854053178
- 30845854053175 BX
- 00845854053174 EA.
Distribution
Distributed nationwide across the United States.
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