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Recall Observatory FDA recall evidence

Device product

DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

Z-2298-2021

June 21, 2021

Class II

Product summary

Firm
Delta Med SpA
Event
Event 88234
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2298-2021

Official wording

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

Code information: a) REF 3832072, Lot 11T80190 b) REF 3810072, Lot 11T80303 c) REF 3842072, Lot 12T80342 d) REF 3852072, Lot 12T80348

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