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Recall Observatory FDA recall evidence

Device product

Venous Access Pack-LF Convenience Kit

Z-0361-2022

October 27, 2021

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 88963
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-0361-2022

Official wording

Reason: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Code information: Model #: DYNJ36725B Lot #: 19UBB149 UDI: GTIN (01)40889942389163 EXP (17)2021-07-31 LOT (10)19UBB149

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.