Fisher Scientific Swabs Recalled for Temperature Excursion During Storage
Mckesson Medical-Surgical Inc. is recalling Fisherbrand laboratory swabs due to facility temperature excursions from June through August 2021 that may have impacted product effectiveness. All affected lots distributed between June 1 and September 30, 2021 are included.
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 2/5 (Moderate).
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 a Class II device recall without reported illnesses, injuries, or confirmed product failures. The hazard is theoretical—temperature exposure may have affected product effectiveness, but no actual failures are documented. The recall is precautionary and qualifies as Moderate severity.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Fisherbrand laboratory swabs (catalog number 1490712) because facility temperature excursions may have compromised product effectiveness.
Between June and August 2021, prior to product delivery, the manufacturing facility experienced temperature excursions. Exposure to higher temperatures during this period may have impacted the swabs' effectiveness.
All lots distributed between June 1, 2021 and September 30, 2021 are affected. These swabs were distributed nationwide in the United States.
Healthcare facilities and laboratories should discontinue use of affected lots and contact their supplier or Mckesson Medical-Surgical Inc. for return and replacement instructions.
The recalled product
- Product
- FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Laboratory Swab
- Affected units
- 154
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 (1)
- GTIN: Unknown
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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