FDA Recall Open, Classified

Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL PACK-LF , Pack Number DYNJ0287720N ; 6) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828Q ; 7) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828R ; 8) STANDARD BASIN PACK-LF, Pack Number DYNJ0420605J ; 9) MINOR BASIN PACK-LF , Pack Number DYNJ0515988L ; 10) MINOR BASIN PACK-LF , Pack Number DYNJ0515988M ; 11) MAJOR BASIN PACK-LF , Pack Number DYNJ0515994Q ; 12) MAJOR BASIN SET-LF, Pack Number DYNJ0551335Q ; 13) MINOR BASIN PACK-LF , Pack Number DYNJ0551725M ; 14) MINOR BASIN PACK, Pack Number DYNJ0557071D ; 15) UROLOGY BASIN PACK-LF , Pack Number DYNJ0561216G ; 16) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907I ; 17) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907K ; 18) LKLND SNGL BASIN PK RFID-LF , Pack Number DYNJ0619907L ; 19) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331G; 20) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331I; 21) TOTAL KNEE BASIN B PACK-LF, Pack Number DYNJ0867555L ; 22) VAG DELIVERY BASIN-LF , Pack Number DYNJ16162I ; 23) MAJOR BASIN PACK, Pack Number DYNJ16629F ; 24) GENERAL BASIN PACK, Pack Number DYNJ16731J ; 25) ST. ANNE'S MINOR BASIN PACK , Pack Number DYNJ24622K ; 26) ST. ANNE'S MAJOR BASIN SET UP , Pack Number DYNJ24628M ; 27) B.A.P BASIN PACK, Pack Number DYNJ28855C ; 28) MAJOR PK W/BASIN MARYVIEW-LF, Pack Number DYNJ30506L ; 29) GYN LAPAROSCOPIC, Pack Number DYNJ31939D ; 30) MAJOR BASIN KIT , Pack Number DYNJ33438G ; 31) BASIN SET , Pack Number DYNJ33967D ; 32) MINOR BASIN PACK-LF , Pack Number DYNJ34575D ; 33) MINOR GEN BASIN PK 9128188-LF , Pack Number DYNJ35972L ; 34) BASIN PACK-LF , Pack Number DYNJ36419D ; 35) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698K ; 36) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698L ; 37) CVG BASIN PACK SC , Pack Number DYNJ38052G ; 38) NEURO BASIN PACK-LF , Pack Number DYNJ39461J ; 39) HEART BASIN TRAY, Pack Number DYNJ44396I ; 40) BASIN PACK, Pack Number DYNJ44706F ; 41) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944D ; 42) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944F ; 43) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991J ; 44) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991N ; 45) RMC BASIN PACK, Pack Number DYNJ48643K ; 46) RMC BASIN PACK, Pack Number DYNJ48643L ; 47) OPEN HEART BASIN PACK-6214, Pack Number DYNJ49530B ; 48) ROBOTIC BASIN PACK, Pack Number DYNJ49536B ; 49) MINOR BASIN PACK, Pack Number DYNJ50463D ; 50) MAJOR BASIN PACK, Pack Number DYNJ50464D ; 51) CSC-N TOWEL SET UP PACK , Pack Number DYNJ50876A ; 52) BASIN SET , Pack Number DYNJ50906F ; 53) PK-SET UP-LF, Pack Number DYNJ51808B ; 54) DOUBLE BASIN OR SET , Pack Number DYNJ51940C ; 55) TR-MINOR KIT-LF , Pack Number DYNJ54801D ; 56) TR-MINOR KIT-LF , Pack Number DYNJ54801F ; 57) TR-MINOR KIT-LF, Pack Number DYNJ54801F ; 58) MAJOR PACK, Pack Number DYNJ55895C ; 59) ORTHO PACK, Pack Number DYNJ55896C ; 60) LITHOTOMY PACK, Pack Number DYNJ55900C ; 61) LAMINECTOMY-DISCECTOMY PACK , Pack Number DYNJ57263B ; 62) BASIN PACK, Pack Number DYNJ57465D ; 63) MAJOR BASIN PACK, Pack Number DYNJ57928C ; 64) PK-MAD,SPINE, Pack Number DYNJ58060I ; 65) SINGLE BASIN PACK-LF, Pack Number DYNJ58389D ; 66) SINGLE BASIN PACK-LF, Pack Number DYNJ58389F ; 67) MINOR SINGLE BASIN-LF , Pack Number DYNJ59649A ; 68) MAJOR BASIN PACK, Pack Number DYNJ59816A ; 69) FLAP PACK , Pack Number DYNJ60224C ; 70) FLAP PACK, Pack Number DYNJ60224D; 71) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529A ; 72) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529B ; 73) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529C ; 74) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529D ; 75) AV FISTULA, Pack Number DYNJ60614C ; 76) BASIN PACK, Pack Number

Recall: Z-3018-2024 · Initiated April 8, 2024

Recall

Recall Number: Z-3018-2024
Event Number: 94583
Firm: MEDLINE INDUSTRIES, LP Northfield
FEI Number: 1417592
Product Code: KDD
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.