FDA Recall Open, Classified

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)

Recall: Z-3006-2024 · Initiated April 8, 2024

Recall

Recall Number: Z-3006-2024
Event Number: 94583
Firm: MEDLINE INDUSTRIES, LP Northfield
FEI Number: 1417592
Product Code: FDE
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.