Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number DYNJ45882A ; 6) TONSIL PACK CATH, Pack Number DYNJ65199A ; 7) CATH PLACEMENT RIB FRACTURE , Pack Number DYNJ66475B ; 8) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211C ; 9) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211CH; 10) UROLOGY PK, Pack Number DYNJ80252C ; 11) PORT INSERTION PACK , Pack Number DYNJ81597
This recall is currently active, issued September 6, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- April 8, 2024
- Posted
- September 6, 2024
- Recall Number
- Z-3010-2024
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution.
Lot / Code Info
CVI4720A , Lot Number 23DLA715 ; CVI4720A , Lot Number 23ELB184 ; CVI4720A , Lot Number 23GLA187 ; CVI4720A , Lot Number 23ILA599 ; CVI4720A , Lot Number 23ILA949 ; CVI4720A , Lot Number 23JLA318 ; CVI4720A , Lot Number 23JLB102 ; CVI4720AH, Lot Number 23DLA715 ; CVI4720AH, Lot Number 23ELB184 ; CVI4720AH, Lot Number 23GLA187 ; CVI4720AH, Lot Number 23ILA599 ; CVI4720AH, Lot Number 23ILA949 ; CVI4720AH, Lot Number 23JLA318 ; CVI4720AH, Lot Number 23JLB102 ; CVI4880, Lot Number 22LBM567 ; CVI4880, Lot Number 23HBU762 ; DYNJ17634D , Lot Number 23LBB611 ; DYNJ45882A , Lot Number 21HBE710 ; DYNJ45882A , Lot Number 21HBO631 ; DYNJ45882A , Lot Number 21JBD536 ; DYNJ45882A , Lot Number 21VBB891 ; DYNJ45882A , Lot Number 22ABC436 ; DYNJ45882A , Lot Number 19ABG982 ; DYNJ45882A , Lot Number 22CBJ819 ; DYNJ45882A , Lot Number 19BBO164 ; DYNJ45882A , Lot Number 19PBB128 ; DYNJ45882A , Lot Number 19EBS629 ; DYNJ45882A , Lot Number 22GBT307 ; DYNJ45882A , Lot Number 19GBY671 ; DYNJ45882A , Lot Number 19HBJ848 ; DYNJ45882A , Lot Number 19HBZ560 ; DYNJ45882A , Lot Number 22KBA300 ; DYNJ45882A , Lot Number 19IBZ258 ; DYNJ45882A , Lot Number 23ABE331 ; DYNJ45882A , Lot Number 20ABD585 ; DYNJ45882A , Lot Number 23DBJ543 ; DYNJ45882A , Lot Number 20ABG271 ; DYNJ45882A , Lot Number 23FBT108 ; DYNJ45882A , Lot Number 23HBC860 ; DYNJ45882A , Lot Number 20GBJ357 ; DYNJ45882A , Lot Number 20HBL822 ; DYNJ45882A , Lot Number 20IBA668 ; DYNJ45882A , Lot Number 20IBC738 ; DYNJ45882A , Lot Number 20KBE707 ; DYNJ45882A , Lot Number 20KBO720 ; DYNJ45882A , Lot Number 20LBY802 ; DYNJ45882A , Lot Number 21CBX085 ; DYNJ65199A , Lot Number 22CBF155 ; DYNJ65199A , Lot Number 22EME843 ; DYNJ65199A , Lot Number 22EME844 ; DYNJ65199A , Lot Number 23AMH680 ; DYNJ65199A , Lot Number 23DMF610 ; DYNJ65199A , Lot Number 23GMA525 ; DYNJ65199A , Lot Number 23HMA956 ; DYNJ65199A , Lot Number 23HMI132 ; DYNJ66475B , Lot Number 22GBM321 ; DYNJ80211C , Lot Number 23GBJ521 ; DYNJ80211C , Lot Number 23GBT960 ; DYNJ80211C , Lot Number 23HBG313 ; DYNJ80211C , Lot Number 23JBQ875 ; DYNJ80211C , Lot Number 23KBM933 ; DYNJ80211C , Lot Number 23LBP433 ; DYNJ80211CH, Lot Number 23GBJ521 ; DYNJ80211CH, Lot Number 23GBT960 ; DYNJ80211CH, Lot Number 23HBG313 ; DYNJ80211CH, Lot Number 23JBQ875 ; DYNJ80211CH, Lot Number 23KBM933 ; DYNJ80211CH, Lot Number 23LBP433 ; DYNJ80252C , Lot Number 23FBM038 ; DYNJ81597, Lot Number 22IBF254 ; DYNJ81597, Lot Number 23BBO299 ; DYNJ81597, Lot Number 23EBW966 ; DYNJ81597, Lot Number 23JBR560 ; DYNJ81597, Lot Number 24ABD028
Root Cause
Under Investigation by firm
Action Taken
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.