RegWardenFDA facility compliance records
Recall

Class II — Cardinal Health 200, LLC

Recalling firmCardinal Health 200, LLC
Registered facilityView this company's 35 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusCompleted
ReasonA degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
ProductPROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
Quantity7119625 total
DistributionUS Nationwide distribution
Initiated2020-07-29
Classified2020-08-28
Recall numberZ-2918-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-2918-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86131/

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