FDA Recall Open, Classified

Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U; 21) RADIOLOGY PACK, Pack Number DYNJ04562S; 22) IR PACK, Pack Number DYNJ04674U; 23) IR PACK, Pack Number DYNJ04674UH; 24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH; 25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG; 26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH; 27) CATH LAB PACK-LF, Pack Number DYNJ0755738R; 28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ; 29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH; 30) CATH LAB PACK , Pack Number DYNJ07919GH; 31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ; 32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ; 33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D; 34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D; 35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH; 36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH; 37) CATH LAB PACK , Pack Number DYNJ10117JH; 38) CARDIAC CATH PACK, Pack Number DYNJ17081S; 39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I; 40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH; 41) ANGIO TRAY, Pack Number DYNJ23438M; 42) ANGIO TRAY, Pack Number DYNJ23438N; 43) ANGIO TRAY, Pack Number DYNJ23438O; 44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q; 45) VIR PACK, Pack Number DYNJ23499MH; 46) HEART CATH-SMH, Pack Number DYNJ24483FH; 47) CATH LAB PACK , Pack Number DYNJ24802PH; 48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH; 49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH; 50) CARDIAC CATH PACK, Pack Number DYNJ26305N; 51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH; 52) HEART CATH LT PACK, Pack Number DYNJ31282I; 53) ANGIO PACK, Pack Number DYNJ31339I; 54) CARDIAC CATH PACK, Pack Number DYNJ31847I; 55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M; 56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M; 57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G; 58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH; 59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F; 60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH; 61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G; 62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G; 63) CARDIAC CATH PACK, Pack Number DYNJ38866F; 64) PERM CATH TRAY, Pack Number DYNJ40423AH; 65) O R EMERGENCY PACK, Pack Number DYNJ40460CH; 66) CARDIAC CATH PACK, Pack Number DYNJ40511M; 67) CATH LAB PACK, Pack Number DYNJ40961A; 68) CARDIAC CATH TRAY, Pack Number DYNJ41050C; 69) CATH LAB PACK, Pack Number DYNJ43469D; 70) PK, RADIOLOGY, Pack Number DYNJ43816B; 71) CARDIAC CATH TRAY, Pack Number DYNJ45323F; 72) LEFT HEART, Pack Number DYNJ45984I; 73) CATH LAB PROCEDURE, Pack Number DYNJ46353F; 74) ANGIO PACK, Pack Number DYNJ46401B; 75) CARDIAC CATH TRAY, Pack Number DYNJ46402A; 76) CARDIAC CATH TRAY, Pack Number DYNJ46419C; 77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D; 78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F; 79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G; 80) NEURO

Recall: Z-2993-2024 · Initiated April 8, 2024

Recall

Recall Number: Z-2993-2024
Event Number: 94583
Firm: MEDLINE INDUSTRIES, LP Northfield
FEI Number: 1417592
Product Code: LDF
Status: Open, Classified
Root Cause: Under Investigation by firm
Initiated: April 8, 2024
Posted: September 6, 2024
Address: 3 Lakes Dr, Northfield, IL, 60093-2753

Description

Reason

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.

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.