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Recall Observatory FDA recall evidence

Device product

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

Z-2296-2021

June 21, 2021

Class II

Product summary

Firm
Delta Med SpA
Event
Event 88234
Status
Ongoing
Classification
Class II
Quantity
203,680 units
Official record key
device-enforcement:Z-2296-2021

Official wording

Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Code information: a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349

Distribution pattern: US Nationwide distribution in the states of FL and MN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Problems related to the sterilization of the medical devices; possible missing sterility of the medical device