FDAClass IIIOctober 5, 2022

a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical recall

a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL…

Why was a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical recalled?

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN: a. 00732224710174; 10732224710171. b. 00732224710433; 10732224710430.

Product
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL…
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
a. 1 box, b. 19 cases.
Distribution
US Nationwide distribution.
Recall date
October 5, 2022
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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