FDAFDA · Food and drugs·Recall number Z-3006-2024

Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ; 7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ; 8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ; 9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ; 10) CYSTO PROCEDURE , Pack Number CDS760062P ; 11) CYSTO PROCEDURE , Pack Number CDS760062Q ; 12) LAPAROSCOPY CDS , Pack Number CDS830216F ; 13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ; 14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ; 15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ; 16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ; 17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ; 18) THOROCOTOMY , Pack Number CDS860040I ; 19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ; 20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ; 21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ; 22) GYN LAP , Pack Number CDS860087K ; 23) GYN LAP , Pack Number CDS860087M ; 24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ; 25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ; 26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ; 27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ; 28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ; 29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ; 30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ; 31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ; 32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ; 33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ; 34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ; 35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ; 36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ; 37) LAPAROSCOPY CDS , Pack Number CDS860194F ; 38) LAPAROSCOPY CDS , Pack Number CDS860194G ; 39) LAPAROSCOPY CDS , Pack Number CDS860194I ; 40) LAPAROSCOPY CDS , Pack Number CDS860229G ; 41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ; 42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ; 43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ; 44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA; 45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB; 46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC; 47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ; 48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ; 49) CYSTO , Pack Number CDS902753F ; 50) LAPAROSCOPIC CDS, Pack Number CDS920043T ; 51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ; 52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ; 53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ; 54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ; 55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ; 56) LAPAROSCOPIC, Pack Number CDS920082X ; 57) LAPAROSCOPIC, Pack Number CDS920082Y ; 58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ; 59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ; 60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ; 61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC; 62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ; 63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ; 64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ; 65) LAP CHOLE CDS-LF, Pack Number CDS930030T ; 66) LAP CHOLE CDS-LF, Pack Number CDS930030U ; 67) LAP CHOLE , Pack Number CDS930089AA; 68) LAP CHOLE CDS , Pack Number CDS930111AA; 69) LAP CHOLE CDS , Pack Number CDS930111AB; 70) LAP CHOLE CDS-LF, Pack Number CDS930117J ; 71) MINOR BASIC-LF, Pack Number CDS930120G ; 72) MINOR BASIC-LF, Pack Number CDS930120I ; 73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ; 74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ; 75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ; 76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ; 77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ; 78)

Published September 18, 2024 · Recall initiated: April 8, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Distributor: Worldwide distribution.
Lot: 7791 , Lot Number 19CDC814 ; 7791 , Lot Number 19EDB234 ; 7791 , Lot Number 19EDC967 ; 7791 , Lot Number 19FDD341 ; 7791 , Lot Number 19GDA594 ; 7791 , Lot Number 19HDC417 ; 7791 , Lot Number 19IDC356 ; 7791 , Lot Number 19KDB323 ; 7791 , Lot Number 19KDB955 ; 7791 , Lot Number 21KDB873 ; 7791 , Lot Number 22CDA330 ; 7791 , Lot Number 22CDA484 ; 7791 , Lot Number 22CDB460 ; CDS760049AC, Lot Number 19KBT844 ; CDS760049AC, Lot Number 20ABJ873 ; CDS760049AC, Lot Number 20BBW737 ; CDS760049AC, Lot Number 20DBL004 ; CDS760049AC, Lot Number 20GBJ882 ; CDS760049AC, Lot Number 20IBH018 ; CDS760049AC, Lot Number 20LBP200 ; CDS760049AC, Lot Number 21ABB006 ; CDS760049AC, Lot Number 21EBA024 ; CDS760049AC, Lot Number 21EBI363 ; CDS760051AB, Lot Number 19ABI119 ; CDS760051AB, Lot Number 19BBP260 ; CDS760051AB, Lot Number 19EBK100 ; CDS760051AB, Lot Number 19EBK170 ; CDS760051AB, Lot Number 19GBH718 ; CDS760051AB, Lot Number 19SBB540 ; CDS760051AB, Lot Number 19SBE251 ; CDS760051AB, Lot Number 19JBP888 ; CDS760051AB, Lot Number 19LBL746 ; CDS760051AC, Lot Number 19WBA844 ; CDS760051AC, Lot Number 19LBY065 ; CDS760051AC, Lot Number 20BBA091 ; CDS760051AC, Lot Number 20BBT794 ; CDS760051AC, Lot Number 20EBU286 ; CDS760051AC, Lot Number 20FBL605 ; CDS760051AC, Lot Number 20GBV069 ; CDS760051AC, Lot Number 20HBO480 ; CDS760051AC, Lot Number 20JBQ421 ; CDS760051AC, Lot Number 20KBL963 ; CDS760051AC, Lot Number 20LBB516 ; CDS760051AC, Lot Number 20LBU992 ; CDS760051AC, Lot Number 21DBV508 ; CDS760051AD, Lot Number 21FBU465 ; CDS760051AD, Lot Number 21HBG002 ; CDS760051AD, Lot Number 21IBP855 ; CDS760051AD, Lot Number 21KBZ599 ; CDS760051AD, Lot Number 21KBZ600 ; CDS760051AD, Lot Number 22DBD548 ; CDS760051AD, Lot Number 22DBG405 ; CDS760051AD, Lot Number 22FBB185 ; CDS760051AD, Lot Number 22FBI490 ; CDS760051AD, Lot Number 22GBD299 ; CDS760051AD, Lot Number 22GBU498 ; CDS760051AD, Lot Number 22IBS739 ; CDS760051AD, Lot Number 22JBF777 ; CDS760051AD, Lot Number 22JBR836 ; CDS760051AD, Lot Number 22KBS068 ; CDS760051AD, Lot Number 23BBG604 ; CDS760051AD, Lot Number 23CBG879 ; CDS760051AD, Lot Number 23FBC729 ; CDS760051AD, Lot Number 23GBD240 ; CDS760051AD, Lot Number 23IBB494 ; CDS760051AD, Lot Number 23IBO569 ; CDS760051AD, Lot Number 23LBE145 ; CDS760051AD, Lot Number 24BBM779 ; CDS760057G , Lot Number 19ABH764 ; CDS760057G , Lot Number 19ABL825 ; CDS760057G , Lot Number 19BBA476 ; CDS760057G , Lot Number 19CBT401 ; CDS760057G , Lot Number 19EBA903 ; CDS760057G , Lot Number 19FBD872 ; CDS760057G , Lot Number 19GBP568 ; CDS760057G , Lot Number 19SBF513 ; CDS760057G , Lot Number 19HBN041 ; CDS760057G , Lot Number 19KBN171 ; CDS760057G , Lot Number 19LBQ707 ; CDS760057G , Lot Number 20BBS579 ; CDS760057G , Lot Number 20OBA112 ; CDS760057I , Lot Number 21FBM605 ; CDS760057I , Lot Number 21HBR385 ; CDS760057I , Lot Number 21IBK118 ; CDS760057I , Lot Number 20EBF638 ; CDS760057I , Lot Number 20GBA315 ; CDS760057I , Lot Number 20HBE854 ; CDS760057I , Lot Number 20IBS984 ; CDS760057I , Lot Number 20KBC976 ; CDS760057I , Lot Number 20LBO858 ; CDS760057I , Lot Number 21BBK105 ; CDS760057I , Lot Number 21CBW931 ; CDS760057I , Lot Number 21EBC903 ; CDS760057J , Lot Number 21JBX790 ; CDS760057J , Lot Number 21LBV289 ; CDS760057J , Lot Number 22NBE608 ; CDS760057J , Lot Number 22OBK791 ; CDS760057J , Lot Number 22DBR270 ; CDS760057J , Lot Number 22FBE976 ; CDS760057J , Lot Number 22FBX954 ; CDS760057J , Lot Number 22HBO176 ; CDS760057J , Lot Number 22HBO511 ; CDS760057K , Lot Number 22LBC409 ; CDS760057K , Lot Number 23ABU244 ; CDS760057K , Lot Number 23CBO552 ; CDS760057K , Lot Number 23CBT750 ; CDS760057K , Lot Number 23EBA183 ; CDS760057K , Lot Number 23EBP896 ; CDS760057K , Lot Number 23GBN928 ; CDS760057K , Lot Number 23IBC604 ; CDS760057K , Lot Number 23JBH987 ; CDS760062P , Lot Number 21FBI200 ; CDS760062P , Lot Number 21HBA510 ; CDS760062P
Risk classification: Class II
Area (FDA): device
Country: United States

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