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
StatusTerminated
ReasonSafety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
ProductMagellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558
Quantity243,250 units
DistributionWorldwide distribution - US Nationwide distribution and the countries of AE, Japan.
Initiated2021-02-09
Classified2021-03-15
Terminated2024-04-09
Recall numberZ-1250-2021
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-1250-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87313/

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