Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3047-2024
• Recall Event ID: 94583
• Product Classification: Circumcision tray - Product Code OHG
• Product: Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A
• Code Information: CDS980371J , Lot Number 19BBJ528 ; CDS980371J , Lot Number 19BBS356 ; CDS980371J , Lot Number 19DBR965 ; CDS980371J , Lot Number 19EBX731 ; CDS980371J , Lot Number 19GBJ926 ; CDS980371J , Lot Number 19HBY831 ; CDS980371J , Lot Number 19IBL323 ; CDS980371K , Lot Number 21GBD850 ; CDS980371K , Lot Number 21HBI925 ; CDS980371K , Lot Number 21JBJ715 ; CDS980371K , Lot Number 19LBF128 ; CDS980371K , Lot Number 20BBU821 ; CDS980371K , Lot Number 20FBB764 ; CDS980371K , Lot Number 20GBR055 ; CDS980371K , Lot Number 20JBT054 ; CDS980371K , Lot Number 20LBC968 ; CDS980371K , Lot Number 21BBE923 ; CDS980371K , Lot Number 21BBG105 ; CDS980371K , Lot Number 21DBL086 ; CIT6260A , Lot Number 22LBQ691 ; CIT6260A , Lot Number 23ABQ560 ; CIT6260A , Lot Number 23EBS513 ; CIT6260A , Lot Number 23HBT731 ; CIT6260A , Lot Number 23LBT432 ; CIT7740, Lot Number 23DBE831 ; CIT7740, Lot Number 23IBR327 ; DYNDL1813, Lot Number 20FBD708 ; DYNJ16826M , Lot Number 20KME235 ; DYNJ16826M , Lot Number 20LMD829 ; 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DYNJ48471D , Lot Number 21LBF729 ; DYNJ48471D , Lot Number 22BBN858 ; DYNJ48471D , Lot Number 22FBA176 ; DYNJ48471D , Lot Number 22GBM022 ; DYNJ48471D , Lot Number 22HBR350 ; DYNJ48471D , Lot Number 19HBG760 ; DYNJ48471D , Lot Number 19IBS581 ; DYNJ48471D , Lot Number 19JBH818 ; DYNJ48471D , Lot Number 23FBD447 ; DYNJ48471D , Lot Number 20KBF714 ; DYNJ48471F , Lot Number 23HBB460 ; DYNJ48471F , Lot Number 23KBH955 ; DYNJ48471F , Lot Number 23KBU382 ; DYNJ61119C , Lot Number 20IBT137 ; DYNJ61119C , Lot Number 20WBI854 ; DYNJ61119C , Lot Number 20LBH019 ; DYNJ61119C , Lot Number 21CBN114 ; DYNJ61119C , Lot Number 21FMD836 ; DYNJ61119C , Lot Number 21GME522 ; DYNJ61119C , Lot Number 21HME553 ; DYNJ61119C , Lot Number 21IMD979 ; DYNJ61119C , Lot Number 21JMA125 ; DYNJ61119C , Lot Number 21KMF555 ; DYNJ61119C , Lot Number 21LMG365 ; DYNJ64432, Lot Number 21IDA848 ; DYNJ64432, Lot Number 21KDC323 ; DYNJ64432, Lot Number 22ADA261 ; DYNJ64432, Lot Number 22CDC116 ; DYNJ64432, Lot Number 22DDC463 ; 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DYNJ64876B , Lot Number 23GBL751 ; DYNJ64876B , Lot Number 23IBP497 ; DYNJ64876B , Lot Number 23JBG687 ; DYNJ64876B , Lot Number 23KBI407 ; DYNJ64876B , Lot Number 24ABA124 ; DYNJ906909A, Lot Number 23ABE857 ; DYNJ906909A, Lot Number 23DBD597 ; DYNJ906909A, Lot Number 23DBE346 ; DYNJ906909A, Lot Number 23FBK478 ; DYNJ906909A, Lot Number 23GBI807 ; DYNJ906909A, Lot Number 23HBR596 ; DYNJ906909A, Lot Number 23IBC034 ; DYNJ906909A, Lot Number 23KBH128 ; DYNJ906909A, Lot Number 24ABT698
• 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.