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Recall Observatory FDA recall evidence

Device product

Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B

Z-2623-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94582
Status
Ongoing
Classification
Class II
Quantity
1,679,067 units in total
Official record key
device-enforcement:Z-2623-2024

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.