SporView Sterilization Biological Indicator Kit Recalled for Temperature Exposure
McKesson is recalling SporView Culture Set biological indicator kits (models CS-020 and CS-100) due to facility temperature excursions that may have compromised product effectiveness. Affected units were distributed nationwide between June and September 2021.
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, but no confirmed failures have been documented. Per the rubric, theoretical hazards without reported harm in Class III recalls score as Moderate (2).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling SporView Culture Set sterilization biological indicator kits, models CS-020 (60-unit quantities) and CS-100 (1-box quantities). These kits are used to validate that sterilization processes are functioning effectively.
The recall was issued due to facility temperature excursions that occurred between June and August 2021, prior to product shipment. Exposure to higher temperatures may have impacted the product's ability to effectively validate sterilization. All lots distributed between June 1, 2021 and September 30, 2021 are affected.
The recalled products were distributed nationwide throughout the United States. Healthcare facilities that received affected units should identify products with the specified lot numbers from the FDA recall notice.
The recalled product
- Product
- a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- thermal-damage
- validation-failure
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 (5)
- GTIN: a. 00732224720074
- 50732224720079
- 10732224720071. b. 00732224720081
- 50732224720086
- 10732224720088.
Distribution
Distributed nationwide across the United States.
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