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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK

Z-2985-2024

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-2985-2024

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: DYNJ59573A , Lot Number 23IBP764 ; DYNJ59573A , Lot Number 23JBM050 ; DYNJ59573A , Lot Number 23KBM610 ; DYNJ59573A , Lot Number 24ABC779 ; DYNJ39451D , Lot Number 22BDB647 ; DYNJ39451D , Lot Number 22CDA099 ; DYNJ39451D , Lot Number 22LDA195 ; DYNJ39451D , Lot Number 23DDB501 ; DYNJ39451D , Lot Number 23DDB666 ; DYNJ39451D , Lot Number 23EDA821 ; DYNJ80281A , Lot Number 23ADA194 ; DYNJ80281A , Lot Number 23DDA881 ; DYNJ80281A , Lot Number 23HDA513 ; DYNJ80281A , Lot Number 23JDC172 ; DYNJ80281A , Lot Number 23LDB860 ; DYNJ80281A , Lot Number 24ADC258 ; DYNJ80281A , Lot Number 24CDA973

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.