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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP

Z-2452-2026

May 06, 2026

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 99043
Status
Ongoing
Classification
Class I
Quantity
227 units
Official record key
device-enforcement:Z-2452-2026

Official wording

Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

Code information: 1) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24GBR740; 2) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24JBP984; 3) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26DBJ110; 4) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABJ069; 5) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABL749; 6) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25CBB762; 7) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25DBG799; 8) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25EBM994; 9) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25GBW226; 10) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBA950; 11) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBT019; 12) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABH519; 13) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABT315; 14) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26BBQ338

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.