Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSER

Summary

The FDA issued a Class II for Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pa by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.

Details

Product Description

Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Number DT19245; 6) BIOPSY KIT, Pack Number DYNDA1466A; 7) BIOPSY KIT, Pack Number DYNDA1466A; 8) CATH REMOVAL, Pack Number DYNDA1733B; 9) CATH REMOVAL, Pack Number DYNDA1814; 10) CATH REMOVAL, Pack Number DYNDA1814; 11) CATH REMOVAL, Pack Number DYNDA1814; 12) CATH REMOVAL, Pack Number DYNDA1814; 13) CATH REMOVAL, Pack Number DYNDA1814; 14) CATH REMOVAL, Pack Number DYNDA1814; 15) CATH REMOVAL, Pack Number DYNDA1814; 16) CATH REMOVAL, Pack Number DYNDA1814; 17) SHUNT TRAY, Pack Number DYNDA2725; 18) PORT ACCESS KIT, Pack Number DYNDC2945; 19) PORT ACCESS KIT, Pack Number DYNDC2945; 20) PORT ACCESS KIT, Pack Number DYNDC2945; 21) PORT ACCESS KIT, Pack Number DYNDC2945; 22) PORT ACCESS KIT, Pack Number DYNDC2945; 23) PORT ACCESS KIT, Pack Number DYNDC2945; 24) PORT ACCESS KIT, Pack Number DYNDC2945; 25) PORT ACCESS KIT, Pack Number DYNDC2945; 26) PORT ACCESS KIT, Pack Number DYNDC2945; 27) PORT ACCESS KIT, Pack Number DYNDC2945; 28) ARTHROGRAM TRAY, Pack Number DYNDH1113; 29) BIOPSY TRAY, Pack Number DYNDH1137C; 30) BIOPSY PACK, Pack Number DYNDH1248; 31) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 32) MYELOGRAM TRAY, Pack Number DYNDH1531; 33) BIOPSY PACK, Pack Number DYNDL1462B; 34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 36) PORT ACCESS TRAY, Pack Number EBSI1241; 37) PORT ACCESS TRAY, Pack Number EBSI1241; 38) PORT ACCESS TRAY, Pack Number EBSI1241; 39) PORT ACCESS TRAY, Pack Number EBSI1241; 40) PORT ACCESS TRAY, Pack Number EBSI1241; 41) PORT ACCESS TRAY, Pack Number EBSI1241; 42) PORT ACCESS TRAY, Pack Number EBSI1241; 43) PORT ACCESS TRAY, Pack Number EBSI1241; 44) PORT ACCESS TRAY, Pack Number EBSI1241; 45) PORT ACCESS TRAY, Pack Number EBSI1241; 46) PORT ACCESS TRAY, Pack Number EBSI1241; 47) PORT ACCESS TRAY, Pack Number EBSI1241; 48) PORT ACCESS TRAY, Pack Number EBSI1241; 49) PORT ACCESS TRAY, Pack Number EBSI1241; 50) PORT ACCESS TRAY, Pack Number EBSI1241; 51) PORT ACCESS TRAY, Pack Number EBSI1241; 52) PORT ACCESS TRAY, Pack Number EBSI1241; 53) PORT ACCESS TRAY, Pack Number EBSI1241; 54) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 55) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 58) OB DELIVERY TRAY, Pack Number MNS10875A; 59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 60) OB DELIVERY SET, Pack Number MNS3355; 61) LUMBAR TRAY, Pack Number SPEC0177; 62) 22G FACET TRAY, Pack Number SPEC0265A; 63) FINE LACERATION KIT, Pack Number SUT19360; 64) LACERATION TRAY, Pack Number SUT20955; 65) LACERATION TRAY, Pack Number SUT3780; 66) LACERATION TRAY, Pack Number SUT3780; 67) SUTURING SET, Pack Number SUT4020

Lot/Code Info: ART245C, Lot Number 2023083090; CHT1900, Lot Number 2020092590; CHT560, Lot Number 2020110590; CHT705, Lot Number 2023011790; DT19245 , Lot Number 21JBN311 ; DYNDA1466A, Lot Number 2021111090; DYNDA1466A, Lot Number 2023091890; DYNDA1733B, Lot Number 2019021950; DYNDA1814, Lot Number 2018103050; DYNDA1814, Lot Number 2018121450; DYNDA1814, Lot Number 2019010950; DYNDA1814, Lot Number 2019021950; DYNDA1814, Lot Number 2019041850; DYNDA1814, Lot Number 2019112250; DYNDA1814, Lot Number 2020031350; DYNDA1814, Lot Number 2020100801; DYNDA2725, Lot Number 2023011790; DYNDC2945, Lot Number 2020071090; DYNDC2945, Lot Number 2020090990; DYNDC2945, Lot Number 2020110590; DYNDC2945, Lot Number 2020122890; DYNDC2945, Lot Number 2021081890; DYNDC2945, Lot Number 2021120890; DYNDC2945, Lot Number 2022121290; DYNDC2945, Lot Number 2023011090; DYNDC2945, Lot Number 2023080790; DYNDC2945, Lot Number 2023091890; DYNDH1113, Lot Number 2020031350; DYNDH1137C, Lot Number 2021011890; DYNDH1248, Lot Number 2019021950; DYNDH1359, Lot Number 2023080790; DYNDH1531, Lot Number 2022020990; DYNDL1462B, Lot Number 2019010950; EBSI1039B, Lot Number 2023083090; EBSI1039B, Lot Number 2023110390; EBSI1241, Lot Number 2019120590; EBSI1241, Lot Number 2020040390; EBSI1241, Lot Number 2020061990; EBSI1241, Lot Number 2020092590; EBSI1241, Lot Number 2020111390; EBSI1241, Lot Number 2021011890; EBSI1241, Lot Number 2021041290; EBSI1241, Lot Number 2021091590; EBSI1241, Lot Number 2021111090; EBSI1241, Lot Number 2021120690; EBSI1241, Lot Number 2022020990; EBSI1241, Lot Number 2022042290; EBSI1241, Lot Number 2022072690; EBSI1241, Lot Number 2022082990; EBSI1241, Lot Number 2022101390; EBSI1241, Lot Number 2023011790; EBSI1241, Lot Number 2023090690; EBSI1241, Lot Number 2023110390; EBSI1453, Lot Number 2022022180; EBSI1453, Lot Number 2022032880; EBSI1453A, Lot Number 2022093090; EBSI1453A, Lot Number 2023083090; MNS10875A, Lot Number 2023011790; MNS12150, Lot Number 2022121290; MNS3355, Lot Number 2020071090; SPEC0177, Lot Number 2019120590; SPEC0265A, Lot Number 2019120590; SUT19360, Lot Number 2022042290; SUT20955, Lot Number 2020092590; SUT3780, Lot Number 2020061990; SUT3780, Lot Number 2020111390; SUT4020, Lot Number 2023091890

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-04-08

Company