Summary
The FDA issued a Class II for Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves by Cardinal Health 200, LLC. Reason: Product was distributed without being sterilized..
Details
Source
Device Recall
External ID
Z-0902-2022
Action Date
2022-04-20
Status
Completed
Category
device
Product Description
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Lot/Code Info: 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
Quantity Affected: 486,578 pairs
Reason for Recall
Product was distributed without being sterilized.
Distribution
Product distributed throughout United States and Guam
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-15
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0902-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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