Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3037-2024
• Recall Event ID: 94583
• 510(K)Number: K962205
• Product Classification: Drape, surgical - Product Code KKX
• Product: Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114
• Code Information: DYNJ0209716K , Lot Number 19ABR348 ; DYNJ0209716K , Lot Number 19CBC954 ; DYNJ0209716K , Lot Number 19CBY010 ; DYNJ0209716K , Lot Number 19PBC426 ; DYNJ0233004D , Lot Number 19BKC696 ; DYNJ0233004D , Lot Number 19EKB353 ; DYNJ0233004D , Lot Number 19EKD788 ; DYNJ0233004D , Lot Number 19IKB771 ; DYNJ0233004D , Lot Number 19JKB511 ; DYNJ0233004D , Lot Number 20AKC285 ; DYNJ0233004D , Lot Number 20CKA142 ; DYNJ0233004D , Lot Number 20EKA118 ; DYNJ0233004D , Lot Number 20EKB817 ; DYNJ0233004D , Lot Number 20FKA173 ; DYNJ0233004D , Lot Number 20HKC130 ; DYNJ0233004D , Lot Number 20LKA046 ; DYNJ0373061J , Lot Number 21IBN110 ; DYNJ0373061J , Lot Number 21IBN112 ; DYNJ0373061J , Lot Number 21IBW039 ; DYNJ0373061J , Lot Number 21JBQ249 ; DYNJ0373061J , Lot Number 21JBQ254 ; DYNJ0373061J , Lot Number 22CBE209 ; DYNJ0373061J , Lot Number 22DBD601 ; DYNJ0373061J , Lot Number 22DBE605 ; DYNJ0373061J , Lot Number 22JBF498 ; DYNJ0373061J , Lot Number 22KBK232 ; DYNJ0373061J , Lot Number 22KBK234 ; DYNJ0373061J , Lot Number 23ABU873 ; DYNJ0373061J , Lot Number 23CBL581 ; DYNJ0373061J , Lot Number 23EBI151 ; DYNJ0373061J , Lot Number 23GBK887 ; DYNJ0373061J , Lot Number 23IBS102 ; DYNJ0373061J , Lot Number 23JBR178 ; DYNJ0373061J , Lot Number 23KBC777 ; DYNJ0373061J , Lot Number 23LBH622 ; DYNJ0373061J , Lot Number 24ABR895 ; DYNJ0373061J , Lot Number 21FBG073 ; DYNJ0373061J , Lot Number 19AKA894 ; DYNJ0373061J , Lot Number 19BKA317 ; DYNJ0373061J , Lot Number 19CKC943 ; DYNJ0373061J , Lot Number 19FKA631 ; DYNJ0373061J , Lot Number 19HKB486 ; DYNJ0373061J , Lot Number 19IKC235 ; DYNJ0373061J , Lot Number 19LKA527 ; DYNJ0373061J , Lot Number 20BKB137 ; DYNJ0373061J , Lot Number 20EKA922 ; DYNJ0373061J , Lot Number 20JKA379 ; DYNJ0373061J , Lot Number 20LKA412 ; DYNJ0406118K , Lot Number 19ABK827 ; DYNJ0406118K , Lot Number 19CBO755 ; DYNJ0406118K , Lot Number 19EBB219 ; DYNJ0406118K , Lot Number 19GBE862 ; DYNJ0406118K , Lot Number 19JBL458 ; DYNJ0618509F , Lot Number 19ABW463 ; DYNJ0618509F , Lot Number 19CBR084 ; DYNJ0618509F , Lot Number 19EBJ402 ; DYNJ0618509F , Lot Number 19FBV871 ; DYNJ0618509F , Lot Number 19HBL361 ; DYNJ0618509F , Lot Number 19VBE228 ; DYNJ0618509F , Lot Number 20ABL413 ; DYNJ0618509F , Lot Number 20DBF289 ; DYNJ0618509F , Lot Number 20EBF874 ; DYNJ22911I , Lot Number 19BBI118 ; DYNJ22911I , Lot Number 19DBF595 ; DYNJ22911I , Lot Number 19GBW575 ; DYNJ22911I , Lot Number 19VBD554 ; DYNJ22911I , Lot Number 19LBP763 ; DYNJ22911I , Lot Number 20BBA910 ; DYNJ22911I , Lot Number 20BBK239 ; DYNJ22911I , Lot Number 20DBG377 ; DYNJ22911I , Lot Number 20EBC409 ; DYNJ22911I , Lot Number 20EBL410 ; DYNJ36314J , Lot Number 19BKA012 ; DYNJ36314J , Lot Number 19CKC650 ; DYNJ36314J , Lot Number 19EKA892 ; DYNJ36314J , Lot Number 19FKB857 ; DYNJ36314J , Lot Number 19HKD378 ; DYNJ37265F , Lot Number 19BBB695 ; DYNJ37265F , Lot Number 19CBI334 ; DYNJ37265F , Lot Number 19PBA263 ; DYNJ37265F , Lot Number 19EBN075 ; DYNJ37265F , Lot Number 19EBW325 ; DYNJ37265F , Lot Number 19RBB628 ; DYNJ37265F , Lot Number 19SBH191 ; DYNJ39689D , Lot Number 19ABT447 ; DYNJ39689D , Lot Number 19CBB349 ; DYNJ39689D , Lot Number 19CBM013 ; DYNJ39689D , Lot Number 19EBJ211 ; DYNJ39689D , Lot Number 19EBS012 ; DYNJ39689D , Lot Number 19HBB315 ; DYNJ39689D , Lot Number 19HBC691 ; DYNJ42065B , Lot Number 19BLA452 ; DYNJ42065B , Lot Number 19CLA566 ; DYNJ42065B , Lot Number 19DLA032 ; DYNJ42065B , Lot Number 19ELA024 ; DYNJ42065B , Lot Number 19FLA415 ; DYNJ42065B , Lot Number 19GLA333 ; DYNJ42065B , Lot Number 19LLA035 ; DYNJ42065B , Lot Number 19LLA221 ; DYNJ42065B , Lot Number 20BLA480 ; DYNJ42065B , Lot Number 20CLA184 ; DYNJ42065B , Lot Number 20FLA227 ; DYNJ42065B , Lot Number 20HLA895 ; DYNJ42065B , Lot Number 20JLA332 ; DYNJ42065B , Lot Number 20KLA470 ; DYNJ42065B , Lot Number 21FLA048 ; DYNJ42065B , Lot Number 21HLA557 ; DYNJ42065B , Lot Number 21HLA596 ; DYNJ42065B , Lot Number 21ILA454 ; DYNJ42065B , Lot Number 21JLA621 ; DYNJ42065B , Lot Number 22CLB117 ; DYNJ42065B , Lot Number 22GLA668 ; DYNJ42065B , Lot Number 22HLA004 ; DYNJ42065B , Lot Number 22JLA859 ; DYNJ42065B , Lot Number 23ELA629 ; DYNJ42065B , Lot Number 23FLA014 ; DYNJ42065B , Lot Number 23GLA520 ; DYNJ42065B , Lot Number 23HLA874 ; DYNJ42065B , Lot Number 24ALA034 ; DYNJ42065B , Lot Number 24CLA157 ; DYNJ43815C , Lot Number 19BBG871 ; DYNJ43815C , Lot Number 19CBQ327 ; DYNJ43815C , Lot Number 19EBA243 ; DYNJ43815C , Lot Number 19EBR588 ; DYNJ43815C , Lot Number 19GBH867 ; DYNJ43815C , Lot Number 19HBM088 ; DYNJ50738, Lot Number 19JLA127 ; DYNJ50738, Lot Number 19LLA497 ; DYNJ50738, Lot Number 20JLA381 ; DYNJ50738, Lot Number 21BLA326 ; DYNJ50738, Lot Number 21ILA351 ; DYNJ50738, Lot Number 21LLA413 ; DYNJ50738, Lot Number 23DLB052 ; DYNJ50738, Lot Number 23FLA753 ; DYNJ50738, Lot Number 24ALA045 ; DYNJ903538C, Lot Number 19IBE935 ; DYNJ903538C, Lot Number 19IBM081 ; DYNJ903538C, Lot Number 19JBU933 ; DYNJ903538C, Lot Number 20ABQ212 ; DYNJ903545C, Lot Number 19FBB458 ; DYNJ903545C, Lot Number 19IBA011 ; DYNJ903545C, Lot Number 19LBJ430 ; DYNJ903545C, Lot Number 20ABT998 ; DYNJ903545C, Lot Number 20DBL053 ; DYNJ903545C, Lot Number 20HBE586 ; DYNJ903545C, Lot Number 21ABL355 ; DYNJ903545C, Lot Number 21BBG940 ; DYNJCD0114 , Lot Number 21EMF296 ; DYNJCD0114 , Lot Number 22CMA466
• 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.

• 510(K) Database: 510(K)s with Product Code = KKX