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Recall

Class II — Delta Med SpA

Recalling firmDelta Med SpA
Registered facilityDelta Med SpA (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonProblems related to the sterilization of the medical devices; possible missing sterility of the medical device
ProductNEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Quantity1400 units
DistributionUS Nationwide distribution in the states of FL and MN.
Initiated2021-06-21
Classified2021-08-16
Recall numberZ-2302-2021
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 — Delta Med SpA (Z-2302-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88234/

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