PROTEXIS recallZ-0902-2022 · Cardinal Health 200, LLC · initiated Mar 15, 2022
Completed
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 Cardinal Health 200, LLC 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
Product was distributed without being sterilized.
FDA root cause category: Under Investigation by firm
What the company is doing
A recall letter dated 03/16/2022 was distributed to impacted consignees. The letter informs consignees that a portion of the distributed lots were distributed without undergoing sterilization. Customers should review their inventory for the impacted lots, segregate and quarantine all affected product, complete the acknowledgement form and return to Cardinal Health. Any customers who may have received further distributed product should be contacted and provided the recall information.
Recall details
- Recall number
- Z-0902-2022
- Status
- Completed
- Initiated by the company
- Mar 15, 2022
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 486,578 pairs
- Product code
- KGO
- FDA submissions
- K110272
- Distribution
- Product distributed throughout United States and Guam
Product description
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Code information (models, lots, serial numbers)
Catalog Numbers: 1) 2D72PL65X, Lot Number TS21050195, EXP 04/30/2024 - UDI on ship case: 50885380031760; UDI on Dispenser carton: 20885380031769; UDI on individual unit: 10885380031762 2) 2D72PT65X, Lot Number TS21050215, EXP 04/30/2024 - UDI on ship case: 50885380031937, UDI on Dispenser carton: 20885380031936; UDI on individual unit: 10885380031939
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- PROTEXIS 2D72PL65XCardinal Health 200, LLC · Surgeon's gloves1 recall0 reports
Product lines
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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