Sterilization Chemical Indicator Strips Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling SPS Medical sterilization indicator strips due to temperature excursions that may have reduced their effectiveness. Products distributed June–September 2021 are affected.
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: FDA Class III recall with no reported sterilization failures or illnesses. The products may not function as intended due to temperature exposure, but this is a precautionary recall based on potential efficacy loss rather than confirmed harm.
Plain-English summary
SPS MEDICAL SUPPLY Steam Indicator Strips (Model SIS-250) and SteamPlus Sterilization Integrators (Model SSI-1000), manufactured by Mckesson Medical-Surgical Inc., are being recalled nationwide due to potential temperature damage.
Between June and August 2021, the products were exposed to elevated temperatures prior to delivery. This exposure may have reduced the ability of the chemical indicators to accurately verify steam sterilization in medical equipment.
All lots received between June 1, 2021, and September 30, 2021, are included in this recall. The products were distributed throughout the United States.
Healthcare facilities and medical professionals should stop using affected units and request replacements from their supplier.
The recalled product
- Product
- a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
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: a. 00732224710174
- 10732224710171. b. 00732224710433
- 10732224710430.
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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