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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223

Z-2991-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94583
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2991-2024

Official wording

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information: DYNJ41223, Lot Number 21HBU861 ; DYNJ41223, Lot Number 21KBA848 ; DYNJ41223, Lot Number 21KBA910 ; DYNJ41223, Lot Number 22ABA546 ; DYNJ41223, Lot Number 22MBA262 ; DYNJ41223, Lot Number 19BBC903 ; DYNJ41223, Lot Number 19CBO901 ; DYNJ41223, Lot Number 19DBW422 ; DYNJ41223, Lot Number 22HBY065 ; DYNJ41223, Lot Number 19HBD957 ; DYNJ41223, Lot Number 19HBJ856 ; DYNJ41223, Lot Number 19IBT476 ; DYNJ41223, Lot Number 22KBU048 ; DYNJ41223, Lot Number 19VBD385 ; DYNJ41223, Lot Number 19LBF954 ; DYNJ41223, Lot Number 23EBC280 ; DYNJ41223, Lot Number 23FBA251 ; DYNJ41223, Lot Number 20BBP883 ; DYNJ41223, Lot Number 20CBI263 ; DYNJ41223, Lot Number 23JBC138 ; DYNJ41223, Lot Number 23KBO541 ; DYNJ41223, Lot Number 20IBJ759 ; DYNJ41223, Lot Number 20JBE058 ; DYNJ41223, Lot Number 20XBF374

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.