Sterilization Roll Recalled Due to Temperature Exposure During Manufacturing
SPS Medical Supply Crosstex sterilization rolls (model SCT3) are being recalled because they were exposed to high temperatures during manufacturing facility storage before shipment. Temperature exposure may have compromised the product's sterilization effectiveness.
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 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 III medical device recall involving a voluntary precautionary recall due to process control issues at the manufacturing facility. No illnesses, injuries, or deaths are mentioned in the source, and the hazard is theoretical—temperature exposure may have compromised product effectiveness.
Plain-English summary
SPS Medical Supply Crosstex International Sterilization Roll Sani-Roll (model SCT3), a 3-inch by 100-foot transparent and blue self-seal paper/film sterilization roll, is being recalled due to potential product effectiveness issues.
From June through August 2021, the manufacturing facility experienced temperature excursions prior to product delivery. Higher temperatures during this period may have compromised the sterilization effectiveness of affected rolls.
The recall affects all lots delivered between June 1, 2021, and September 30, 2021. The product was distributed nationwide in the United States.
Users should discontinue use of affected sterilization rolls and contact the manufacturer, Mckesson Medical-Surgical Inc., for replacement options and additional information.
The recalled product
- Product
- SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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: 00732224109824
- 50732224109829
- 10732224109821
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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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