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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206

Z-3032-2024

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-3032-2024

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: DYNJSYR12CP, Lot Number 19ABK425 ; DYNJSYR12CP, Lot Number 19ABK443 ; 148056, Lot Number 24DMC306; 148056, Lot Number 23LMI229; 148056, Lot Number 23JMH148; 148056, Lot Number 23JMA243; 148056, Lot Number 23IMB662; 148056, Lot Number 23HMG815; 150206, Lot Number 23LME712

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.