—#208012

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

FDA product code: OFQ — Anesthesia Kit
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-04-08
Posted by FDA: 2024-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.