Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3061-2024
• Recall Event ID: 94583
• Product Classification: Burn kit without drug - Product Code OJJ
• Product: Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN PACK , Pack Number DYNJ69770A ; 7) SMALL BURN PACK , Pack Number DYNJ69797; 8) SMALL BURN PACK , Pack Number DYNJ69797A ; 9) BURN PACK-LF, Pack Number DYNJ82534; 10) BURN PACK-LF, Pack Number DYNJ82534H ; 11) BASIC BURN PACK , Pack Number DYNJ82729; 12) BURN PACK , Pack Number DYNJ83254; 13) BURN PACK , Pack Number DYNJ84744
• Code Information: DYNJ0781678S , Lot Number 19LMC634 ; DYNJ0781678S , Lot Number 20AMD173 ; DYNJ0781678S , Lot Number 20CMC665 ; DYNJ0781678S , Lot Number 20EMB965 ; DYNJ0781678S , Lot Number 20GMC952 ; DYNJ0781678S , Lot Number 20JMD288 ; DYNJ0781678S , Lot Number 21CMB052 ; DYNJ0781678S , Lot Number 21CME303 ; DYNJ0781678S , Lot Number 21GME666 ; DYNJ0781678S , Lot Number 21IMD184 ; DYNJ0781678S , Lot Number 21KMG512 ; DYNJ0781678S , Lot Number 22AMF686 ; DYNJ0781678S , Lot Number 22BMA737 ; DYNJ0781678S , Lot Number 22DMI132 ; DYNJ0781678S , Lot Number 22EMB432 ; DYNJ0781678S , Lot Number 22EMI061 ; DYNJ0781678S , Lot Number 22GMB212 ; DYNJ0781678S , Lot Number 22IMC056 ; DYNJ0781678S , Lot Number 22KMB510 ; DYNJ0781678S , Lot Number 23AMD737 ; DYNJ0781678S , Lot Number 23BMC741 ; DYNJ0781678S , Lot Number 23CMG452 ; DYNJ0781678S , Lot Number 23EMJ106 ; DYNJ0781678S , Lot Number 23GMC393 ; DYNJ0781678S , Lot Number 23HMB925 ; DYNJ0781678S , Lot Number 23HMI837 ; DYNJ0781678S , Lot Number 23JME009 ; DYNJ0781678S , Lot Number 23LMG524 ; DYNJ0976092P , Lot Number 22KBM419 ; DYNJ0976092P , Lot Number 23ABI393 ; DYNJ0976092P , Lot Number 23ABU953 ; DYNJ0976092P , Lot Number 23CBO918 ; DYNJ0976092P , Lot Number 23FBK157 ; DYNJ0976092P , Lot Number 23FBO968 ; DYNJ0976092P , Lot Number 23HBP114 ; DYNJ0976092P , Lot Number 23JBJ268 ; DYNJ0976092P , Lot Number 23JBX458 ; DYNJ0976092P , Lot Number 23LBO309 ; DYNJ42829B , Lot Number 21VBB243 ; DYNJ42829B , Lot Number 21KBX160 ; DYNJ42829B , Lot Number 21LBJ187 ; DYNJ42829B , Lot Number 22CBG053 ; DYNJ42829B , Lot Number 22DBM155 ; DYNJ42829B , Lot Number 22EBF406 ; DYNJ42829B , Lot Number 22EBQ033 ; DYNJ42829B , Lot Number 22HBL593 ; DYNJ42829B , Lot Number 22IBI084 ; DYNJ42829B , Lot Number 22JBT931 ; DYNJ54386C , Lot Number 21HMA145 ; DYNJ54386C , Lot Number 21HMF539 ; DYNJ54386C , Lot Number 22CMC496 ; DYNJ54386C , Lot Number 22EMA072 ; DYNJ54386C , Lot Number 22GMC085 ; DYNJ54386C , Lot Number 22HMC997 ; DYNJ54386C , Lot Number 23BMD997 ; DYNJ54386C , Lot Number 23BME291 ; DYNJ54386C , Lot Number 23BME299 ; DYNJ54386C , Lot Number 23HMD808 ; DYNJ54386C , Lot Number 23JME585 ; DYNJ54386C , Lot Number 23KMJ519 ; DYNJ54386C , Lot Number 24AMA687 ; DYNJ69770, Lot Number 21JBZ854 ; DYNJ69770, Lot Number 21KBG572 ; DYNJ69770, Lot Number 22FBF083 ; DYNJ69770, Lot Number 22GBS150 ; DYNJ69770, Lot Number 22IBI498 ; DYNJ69770, Lot Number 22IBI500 ; DYNJ69770, Lot Number 23ABF148 ; DYNJ69770A , Lot Number 23BBM922 ; DYNJ69770A , Lot Number 23BBN136 ; DYNJ69770A , Lot Number 23DBB253 ; DYNJ69770A , Lot Number 23GBE013 ; DYNJ69770A , Lot Number 23HBP947 ; DYNJ69770A , Lot Number 23IBD392 ; DYNJ69770A , Lot Number 23LBH034 ; DYNJ69770A , Lot Number 24ABD199 ; DYNJ69797, Lot Number 21VBB057 ; DYNJ69797, Lot Number 22FBU011 ; DYNJ69797, Lot Number 22IBL650 ; DYNJ69797, Lot Number 22JBS235 ; DYNJ69797, Lot Number 22LBN180 ; DYNJ69797A , Lot Number 23ABR780 ; DYNJ69797A , Lot Number 23CBC665 ; DYNJ69797A , Lot Number 23DBA361 ; DYNJ69797A , Lot Number 23DBP443 ; DYNJ69797A , Lot Number 23FBD706 ; DYNJ69797A , Lot Number 23GBH073 ; DYNJ69797A , Lot Number 23IBI641 ; DYNJ69797A , Lot Number 23JBM947 ; DYNJ82534, Lot Number 22HBI219 ; DYNJ82534, Lot Number 23ABI062 ; DYNJ82534, Lot Number 23ABI245 ; DYNJ82534, Lot Number 23ABT142 ; DYNJ82534, Lot Number 23CBA657 ; DYNJ82534, Lot Number 23FBA414 ; DYNJ82534, Lot Number 23GBB353 ; DYNJ82534, Lot Number 23HBN063 ; DYNJ82534, Lot Number 23IBO398 ; DYNJ82534, Lot Number 23KBP925 ; DYNJ82534H , Lot Number 22HBI219 ; DYNJ82534H , Lot Number 23ABI062 ; DYNJ82534H , Lot Number 23ABI245 ; DYNJ82534H , Lot Number 23ABT142 ; DYNJ82534H , Lot Number 23CBA657 ; DYNJ82534H , Lot Number 23FBA414 ; DYNJ82534H , Lot Number 23GBB353 ; DYNJ82534H , Lot Number 23HBN063 ; DYNJ82534H , Lot Number 23IBO398 ; DYNJ82534H , Lot Number 23KBP925 ; DYNJ82729, Lot Number 22KMF062 ; DYNJ82729, Lot Number 23CMF962 ; DYNJ82729, Lot Number 23DMG875 ; DYNJ82729, Lot Number 23EME128 ; DYNJ82729, Lot Number 23FMB967 ; DYNJ82729, Lot Number 23GMD583 ; DYNJ82729, Lot Number 23IMG264 ; DYNJ82729, Lot Number 23LMF995 ; DYNJ82729, Lot Number 24AMC492 ; DYNJ83254, Lot Number 22LBO275 ; DYNJ83254, Lot Number 23CBM480 ; DYNJ84744, Lot Number 23GMF409
• 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.