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Recall Observatory FDA recall evidence

Device product

Bedside PICC CDS Convenience Kit

Z-0362-2022

October 27, 2021

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 88963
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0362-2022

Official wording

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

Code information: Model #: CDS984642 Lot #: 19JBB553 UDI: GTIN (01)40884389882825 EXP (17)2021-09-30 LOT (10)19JBB553

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.