VERIFY recallZ-1313-2024 · Mckesson Medical-Surgical Inc. Corporate Office · initiated Jan 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mckesson Medical-Surgical Inc. Corporate Office or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
FDA root cause category: Storage
What the company is doing
McKesson notified customers by phone January 9, 2024 with a follow-up call January 17, 2024 instructing customers of three scenarios based upon the products they received and the investigation in conjunction with relevant manufacturer. The firm also sent Urgent Product Recall Notifications via email on February 8, 2024 instructing customers to immediately examine inventory and quarantine all affected devices, complete and return the provided response form to [email protected], and notify customers who you have further distributed recalled devices to of this recall and to segregate and quarantine any devices they have on hand. Replacement products will be provided and may have the same lot number(s) as the recalled items but are not affected by the recall and are acceptable for use. Customers with questions can contact McKesson directly by phone at (800) 688-8840. Representatives are available Monday to Friday, 8:00 am to 5:00 pm PST.
Recall details
- Recall number
- Z-1313-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 9, 2024
- Posted by the FDA
- Mar 19, 2024
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 25 units
- Product code
- MNL
- Distribution
- US Nationwide distribution in the states of AZ, PA and TX.
Product description
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Code information (models, lots, serial numbers)
Catalogue Number: LCC101; UDI/DI: 10724995220072
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VERIFY LCC101Steris Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94024).
- Z-1312-2024 · Open, ClassifiedAbbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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