Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3024-2024
• Recall Event ID: 94583
• Product Classification: Skin prep tray - Product Code OJU
• Product: Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY , Pack Number DYNDC3282; 7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ; 8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ; 9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ; 10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ; 11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ; 12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ; 13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ; 14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ; 15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ; 16) PK-SETUP PACK , Pack Number DYNJ43804A ; 17) SKIN LESION PACK, Pack Number DYNJ44258G ; 18) SETUP PACK, Pack Number DYNJ46187D ; 19) PK-SET UP -LF , Pack Number DYNJ53220B ; 20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ; 21) SKIN SCRUB PACK , Pack Number DYNJ68561; 22) DMEK PREP PACK, Pack Number DYNJ81659A ; 23) SET UP PACK , Pack Number DYNJ84247; 24) BASIC SET UP PACK-LF, Pack Number DYNJ85036; 25) SET UP CDS-ASC, Pack Number DYNJ900073C; 26) GENERAL SET UP, Pack Number DYNJ906282C; 27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A; 28) SET UP, Pack Number DYNJ909403 ; 29) PREP TRAY , Pack Number DYNJRA1280A; 30) PREP TRAY , Pack Number DYNJRA1424 ; 31) NERVE BLOCK/W , Pack Number DYNJRA1424H; 32) PREP TRAY, Pack Number DYNJRA1498B; 33) PREP TRAY , Pack Number DYNJRA1583C; 34) PREP TRAY , Pack Number DYNJRA1760 ; 35) PREP TRAY , Pack Number DYNJRA1774 ; 36) PREP TRAY , Pack Number DYNJRA1783 ; 37) PREP TRAY , Pack Number DYNJRA1946A; 38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ; 39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A
• Code Information: DYNDA1540, Lot Number 23JBV995; DYNDA1540, Lot Number 23GBA155; DYNDA1540, Lot Number 23EBB508; DYNDA1540, Lot Number 22LBK096; DYNDA1540, Lot Number 22JBQ748; DYNDA1540, Lot Number 22HBC421; DYNDA1540, Lot Number 22DBP691; DYNDA1540, Lot Number 22ABU584; DYNDA1540, Lot Number 21BBI623; DYNDA1540, Lot Number 20LBU589; DYNDA1540, Lot Number 20KBL865; DYNDA1540, Lot Number 20JBP526; DYNDA1540, Lot Number 20IBD073; DYNDA1540, Lot Number 20HBT535; DYNDA1540, Lot Number 20HBQ630; DYNDA1540, Lot Number 20HBB154; DYNDA1540, Lot Number 2019050290; DYNDA1540, Lot Number 2019061890; DYNDA1540, Lot Number 2019071290; DYNDA2499, Lot Number 21JBI254 ; DYNDA2519, Lot Number 22FBC352 ; DYNDA2519H , Lot Number 22FBC352 ; DYNDA3076, Lot Number 24ABU746 ; DYNDC3282, Lot Number 23CLA266 ; DYNDC3282, Lot Number 23DLA289 ; DYNDC3282, Lot Number 23FLA594 ; DYNDC3282A , Lot Number 23HLA208 ; DYNDC3282A , Lot Number 23ILA470 ; DYNDC3282B , Lot Number 23LLA874 ; DYNDC3282B , Lot Number 24CLA486 ; DYNJ0618280G , Lot Number 19BBA500 ; DYNJ0618280G , Lot Number 19BBK048 ; DYNJ0618280I , Lot Number 21HBF705 ; DYNJ0618280I , Lot Number 22EBJ300 ; DYNJ0618280I , Lot Number 19PBC248 ; DYNJ0618280I , Lot Number 19HBJ382 ; DYNJ0618280I , Lot Number 20BBX426 ; DYNJ0618280I , Lot Number 20DBN589 ; DYNJ0618280I , Lot Number 20EBF905 ; DYNJ0618280I , Lot Number 20IBA358 ; DYNJ0618280I , Lot Number 20IBJ312 ; DYNJ0618280I , Lot Number 20JBO345 ; DYNJ0618280J , Lot Number 22LBE471 ; DYNJ0618280J , Lot Number 23GBW260 ; DYNJ0618280J , Lot Number 23KBE106 ; DYNJ0738967A , Lot Number 19ABK292 ; DYNJ0738967A , Lot Number 19ABS637 ; DYNJ0738967A , Lot Number 19BBC096 ; DYNJ0738967A , Lot Number 19FBG026 ; DYNJ0738967A , Lot Number 19GBT425 ; DYNJ0738967A , Lot Number 19IBM307 ; DYNJ0738967A , Lot Number 19KBP191 ; DYNJ0738967A , Lot Number 20ABR041 ; DYNJ0738967A , Lot Number 20BBP817 ; DYNJ0738967A , Lot Number 20CBU110 ; DYNJ0738967A , Lot Number 20DBV286 ; DYNJ0738967A , Lot Number 20EBF979 ; DYNJ0738967A , Lot Number 20EBL088 ; DYNJ0738967A , Lot Number 20FBH972 ; DYNJ0738967A , Lot Number 20HBJ232 ; DYNJ28988I , Lot Number 23FLA367 ; DYNJ28988I , Lot Number 23GLA394 ; DYNJ28988I , Lot Number 23GLB068 ; DYNJ28988I , Lot Number 23HLA778 ; DYNJ28988I , Lot Number 23JLA349 ; DYNJ28988I , Lot Number 23JLB091 ; DYNJ28988I , Lot Number 23LLA861 ; DYNJ28988I , Lot Number 24BLA093 ; DYNJ28988I , Lot Number 23LLA359 ; DYNJ28988I , Lot Number 24CLA351 ; DYNJ36311A , Lot Number 19BKC718 ; DYNJ36311A , Lot Number 19CKC109 ; DYNJ43804A , Lot Number 23ABS693 ; DYNJ43804A , Lot Number 23DBJ631 ; DYNJ43804A , Lot Number 23GBS752 ; DYNJ43804A , Lot Number 23HBR871 ; DYNJ43804A , Lot Number 23KBE834 ; DYNJ43804A , Lot Number 23LBL776 ; DYNJ44258G , Lot Number 21ADB154 ; DYNJ46187D , Lot Number 23IMH258 ; DYNJ46187D , Lot Number 23LMD118 ; DYNJ53220B , Lot Number 22LMF612 ; DYNJ53220B , Lot Number 23BMH755 ; DYNJ53220B , Lot Number 23DMB617 ; DYNJ53220B , Lot Number 23EME353 ; DYNJ53220B , Lot Number 23FMC893 ; DYNJ53220B , Lot Number 23FMJ703 ; DYNJ53220B , Lot Number 23IMH249 ; DYNJ53220B , Lot Number 23KMA406 ; DYNJ53220B , Lot Number 24AMC542 ; DYNJ64857A , Lot Number 23GMB325 ; DYNJ68561, Lot Number 21GBT186 ; DYNJ68561, Lot Number 21HBN324 ; DYNJ68561, Lot Number 21IBF299 ; DYNJ68561, Lot Number 21JBU945 ; DYNJ68561, Lot Number 21KBR048 ; DYNJ68561, Lot Number 22ABE326 ; DYNJ68561, Lot Number 22CBZ837 ; DYNJ68561, Lot Number 22EBR300 ; DYNJ68561, Lot Number 22GBR532 ; DYNJ68561, Lot Number 22IBA354 ; DYNJ68561, Lot Number 22KBA954 ; DYNJ68561, Lot Number 23BBD411 ; DYNJ68561, Lot Number 23CBR350 ; DYNJ68561, Lot Number 23DBJ393 ; DYNJ68561, Lot Number 23EBJ138 ; DYNJ68561, Lot Number 23FBI706 ; DYNJ68561, Lot Number 23GBK621 ; DYNJ68561, Lot Number 23IBL911 ; DYNJ68561, Lot Number 23KBJ288 ; DYNJ68561, Lot Number 23LBN184 ; DYNJ68561, Lot Number 21CBA125 ; DYNJ68561, Lot Number 21EBO241 ; DYNJ81659A , Lot Number 22KBK040 ; DYNJ84247, Lot Number 23DBF655 ; DYNJ84247, Lot Number 23KBO915 ; DYNJ85036, Lot Number 23IBO065 ; DYNJ900073C, Lot Number 23GMG877 ; DYNJ900073C, Lot Number 23IMB632 ; DYNJ900073C, Lot Number 23JMH955 ; DYNJ900073C, Lot Number 23KME142 ; DYNJ906282C, Lot Number 23EMH718 ; DYNJ906282C, Lot Number 23EMI365 ; DYNJ906282C, Lot Number 23GMG364 ; DYNJ906282C, Lot Number 23GMH729 ; DYNJ906282C, Lot Number 23KMC248 ; DYNJ906282C, Lot Number 23LME074 ; DYNJ909261A, Lot Number 24ABA886 ; DYNJ909403 , Lot Number 23BMH377 ; DYNJ909403 , Lot Number 23CMC605 ; DYNJ909403 , Lot Number 23CMG979 ; DYNJ909403 , Lot Number 23EMD386 ; DYNJ909403 , Lot Number 23HMC288 ; DYNJ909403 , Lot Number 23HMI268 ; DYNJ909403 , Lot Number 23JMJ496 ; DYNJ909403 , Lot Number 23LMG588 ; DYNJRA1280A, Lot Number 19DDB134 ; DYNJRA1280A, Lot Number 19EDA093 ; DYNJRA1280A, Lot Number 19FDA364 ; DYNJRA1280A, Lot Number 19GDB114 ; DYNJRA1424 , Lot Number 19SBF926 ; DYNJRA1424 , Lot Number 22LBJ843 ; DYNJRA1424 , Lot Number 19JBQ794 ; DYNJRA1424 , Lot Number 19JBU300 ; DYNJRA1424 , Lot Number 19KBU269 ; DYNJRA1424 , Lot Number 19KBU874 ; DYNJRA1424 , Lot Number 23DBO709 ; DYNJRA1424 , Lot Number 23JBB394 ; DYNJRA1424 , Lot Number 23JBO140 ; DYNJRA1424H, Lot Number 19SBF926 ; DYNJRA1424H, Lot Number 22LBJ843 ; DYNJRA1424H, Lot Number 19JBQ794 ; DYNJRA1424H, Lot Number 19JBU300 ; DYNJRA1424H, Lot Number 19KBU269 ; DYNJRA1424H, Lot Number 19KBU874 ; DYNJRA1424H, Lot Number 23DBO709 ; DYNJRA1424H, Lot Number 23JBB394 ; DYNJRA1424H, Lot Number 23JBO140 ; DYNJRA1498B, Lot Number 23LBH684; DYNJRA1498B, Lot Number 23KBM001; DYNJRA1498B, Lot Number 23HBR192; DYNJRA1498B, Lot Number 23HBQ223; DYNJRA1583C, Lot Number 22IBA106 ; DYNJRA1583C, Lot Number 22IBM619 ; DYNJRA1583C, Lot Number 22JBG212 ; DYNJRA1583C, Lot Number 23ABG207 ; DYNJRA1760 , Lot Number 21FBK824 ; DYNJRA1760 , Lot Number 21GBQ183 ; DYNJRA1760 , Lot Number 21HBG758 ; DYNJRA1760 , Lot Number 21JBD045 ; DYNJRA1760 , Lot Number 21KBF195 ; DYNJRA1760 , Lot Number 21CBP879 ; DYNJRA1774 , Lot Number 21EBN794 ; DYNJRA1783 , Lot Number 21HBO497 ; DYNJRA1783 , Lot Number 21JBT912 ; DYNJRA1783 , Lot Number 22ABA947 ; DYNJRA1783 , Lot Number 21DBU350 ; DYNJRA1783 , Lot Number 22LMJ331 ; DYNJRA1783 , Lot Number 23DMA884 ; DYNJRA1946A, Lot Number 23IBN848 ; PHS627837003 , Lot Number 21GBD048 ; PHS627837003 , Lot Number 21IBK924 ; PHS627837003 , Lot Number 21JBI944 ; PHS627837003 , Lot Number 21JBZ984 ; PHS627837003 , Lot Number 21KBQ074 ; PHS627837003 , Lot Number 21LBI926 ; PHS627837003 , Lot Number 20LBL907 ; PHS627837003 , Lot Number 21ABL868 ; PHS627837003 , Lot Number 21CBY701 ; PHS627837003A, Lot Number 22EBS057 ; PHS627837003A, Lot Number 22HBO070 ; PHS627837003A, Lot Number 22IBF110 ; PHS627837003A, Lot Number 22KBL329 ; PHS627837003A, Lot Number 23DBN960 ; PHS627837003A, Lot Number 23FBP926 ; PHS627837003A, Lot Number 23HBT307 ; PHS627837003A, Lot Number 23JBL440 ; PHS627837003A, Lot Number 23JBY708 ; PHS627837003A, Lot Number 23KBP182
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.