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Recall Observatory FDA recall evidence

Device product

Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098

Z-2762-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94581
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2762-2024

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: DYNJ908584 , Lot Numbers: 22DBL462; DYNJ908584 , Lot Numbers: 22JBS694; DYNJ908584 , Lot Numbers: 23CBQ227; DYNJ908584 , Lot Numbers: 23FBT227; DYNJ908584A, Lot Numbers: 23HBQ685; DYNJ908584A, Lot Numbers: 23JBT134; DYNJ908584A, Lot Numbers: 23LBE682; DYNJ908584A, Lot Numbers: 24CBH741; DYNJ909098 , Lot Numbers: 22LBS559; DYNJ909098 , Lot Numbers: 23EBQ496; DYNJ909098 , Lot Numbers: 23FBG194; DYNJ909098 , Lot Numbers: 23GBK039; DYNJ909098 , Lot Numbers: 23GBQ855; DYNJ909098 , Lot Numbers: 23IBK300; DYNJ909098 , Lot Numbers: 23IBQ772

Distribution pattern: Worldwide

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.