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Recall Observatory FDA recall evidence

Device product

MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561

Z-0121-2023

September 09, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 90911
Status
Ongoing
Classification
Class II
Quantity
1020 kits
Official record key
device-enforcement:Z-0121-2023

Official wording

Reason: Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

Code information: UDI/DI: (01)40193489402811 (case), (01)10193489402810 (kit), Lot Number 22FMF307

Distribution pattern: US Nationwide distribution in the state of California.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.