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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYNJ54607A ; 3) LOCAL PACK, Pack Number DYNJ61839B

Z-3055-2024

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-3055-2024

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: DYNJ34129C , Lot Number 21GBT130 ; DYNJ34129C , Lot Number 21LBL623 ; DYNJ34129C , Lot Number 22ABM033 ; DYNJ34129C , Lot Number 22ABX499 ; DYNJ34129C , Lot Number 19BBD954 ; DYNJ34129C , Lot Number 19DBZ455 ; DYNJ34129C , Lot Number 19EBU077 ; DYNJ34129C , Lot Number 19GBU537 ; DYNJ34129C , Lot Number 22IBG550 ; DYNJ34129C , Lot Number 19JBN034 ; DYNJ34129C , Lot Number 20BBF056 ; DYNJ34129C , Lot Number 23FBG792 ; DYNJ34129C , Lot Number 23GBE376 ; DYNJ34129C , Lot Number 20FBS002 ; DYNJ34129C , Lot Number 23JBR570 ; DYNJ34129C , Lot Number 23JBY629 ; DYNJ34129C , Lot Number 23KBU960 ; DYNJ34129C , Lot Number 23KBW607 ; DYNJ34129C , Lot Number 20KBW597 ; DYNJ34129C , Lot Number 20LBM567 ; DYNJ34129C , Lot Number 21EBA688 ; DYNJ54607A , Lot Number 21HBS933 ; DYNJ54607A , Lot Number 21JBH960 ; DYNJ54607A , Lot Number 21JBZ002 ; DYNJ54607A , Lot Number 21LBJ925 ; DYNJ54607A , Lot Number 19BBP092 ; DYNJ54607A , Lot Number 19CBB568 ; DYNJ54607A , Lot Number 22GBH746 ; DYNJ54607A , Lot Number 22GBZ352 ; DYNJ54607A , Lot Number 19GBT320 ; DYNJ54607A , Lot Number 22IBG226 ; DYNJ54607A , Lot Number 19VBA464 ; DYNJ54607A , Lot Number 19LBN255 ; DYNJ54607A , Lot Number 23EBA098 ; DYNJ54607A , Lot Number 20DBI269 ; DYNJ54607A , Lot Number 20GBW370 ; DYNJ54607A , Lot Number 21ABE502 ; DYNJ54607A , Lot Number 21ABO952 ; DYNJ54607A , Lot Number 21ABT074 ; DYNJ61839B , Lot Number 21JBP698 ; DYNJ61839B , Lot Number 21LBL729 ; DYNJ61839B , Lot Number 22ABU420 ; DYNJ61839B , Lot Number 22EBJ226 ; DYNJ61839B , Lot Number 22HBA748 ; DYNJ61839B , Lot Number 22IBR542 ; DYNJ61839B , Lot Number 19IBN952 ; DYNJ61839B , Lot Number 19LBT615 ; DYNJ61839B , Lot Number 23EBD346 ; DYNJ61839B , Lot Number 23GBE331 ; DYNJ61839B , Lot Number 20DBD020 ; DYNJ61839B , Lot Number 20GBV525 ; DYNJ61839B , Lot Number 20JBC796 ; DYNJ61839B , Lot Number 24ABV143 ; DYNJ61839B , Lot Number 20KBZ290 ; DYNJ61839B , Lot Number 21DBR237 ; DYNJ61839B , Lot Number 21EBP718 ;

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.