MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-2772-2024)

Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX TRAY, Pack Number DYNDH1050A; 7) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 8) CATHETER ON/OFF KIT, Pack Number DT5490B; 9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 10) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 11) CIRCUMCISION TRAY, Pack Number CIT6260; 12) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 13) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 14) DELIVERY PACK, Pack Number MNS2925A; 15) DELIVERY PACK, Pack Number MNS2925B; 16) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 17) FINE LACERATION KIT, Pack Number SUT19360; 18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B; 19) GENERAL UTILITY, Pack Number DYNDA2524; 20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 23) LACERATION TRAY, Pack Number DYNDL1757; 24) MYELOGRAM TRAY, Pack Number DYNDH1531; 25) OB DELIVERY SET, Pack Number MNS3355; 26) OB DELIVERY TRAY, Pack Number MNS10875; 27) OB DELIVERY TRAY, Pack Number MNS5575; 28) OB DELIVERY TRAY, Pack Number MNS10875A; 29) PICU LINE TRAY, Pack Number DYNDC1960A; 30) PORT ACCESS KIT, Pack Number DYNDC2945; 31) PORT ACCESS TRAY, Pack Number EBSI1241; 32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A; 33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 34) SUTURING SET, Pack Number SUT9790; 35) SUTURING SET, Pack Number SUT4020; 36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A; 37) U.A.C. TRAY, Pack Number UVT125; 38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020; 40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A

Class II

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.

DYNDH1349, Lot Number 2019061090; SPEC0400, Lot Number 2022010790; SPEC0400, Lot Number 2022061490; PT220, Lot Number 2020090390; DYNDH1570, Lot Number 2023091390; SPEC4380, Lot Number 2023110890; DYNDH1050A, Lot Number 2019100490; SPEC0130C, Lot Number 2020072090; DT5490B, Lot Number 2022091590; S5078BF09, Lot Number 2022122390; CHT705, Lot Number 2021072990; CIT6260, Lot Number 2022031190; MNS4815, Lot Number 2022042890; MNS6496, Lot Number 2018112690; MNS6496, Lot Number 2019061390; MNS6496, Lot Number 2020040190; MNS6496, Lot Number 2020062290; MNS6496, Lot Number 2020090290; MNS6496, Lot Number 2021072990; MNS6496, Lot Number 2022010790; MNS6496, Lot Number 2022080890; MNS6496, Lot Number 2022122390; MNS6496, Lot Number 2023040690; MNS2925A, Lot Number 2019080690; MNS2925A, Lot Number 2019101190; MNS2925B, Lot Number 2020032090; MNS2925B, Lot Number 2020071690; DYNDL1187A, Lot Number 2019080590; DYNDL1187A, Lot Number 2019100490; SUT19360, Lot Number 2023021090; SPEC0248B, Lot Number 2019041790; DYNDA2524, Lot Number 2019100490; DYNDH1227A, Lot Number 2019061090; DYNDH1227B, Lot Number 2019100490; MNS12150, Lot Number 2021072990; MNS12150, Lot Number 2022031190; DYNDL1757, Lot Number 2019061090; DYNDH1531, Lot Number 2023021090; MNS3355, Lot Number 2019080590; MNS3355, Lot Number 2019100490; MNS3355, Lot Number 2020050890; MNS3355, Lot Number 2020091090; MNS3355, Lot Number 2020113090; MNS3355, Lot Number 2021030890; MNS3355, Lot Number 2021040990; MNS3355, Lot Number 2021052890; MNS3355, Lot Number 2021071590; MNS3355, Lot Number 2021080990; MNS3355, Lot Number 2021122390; MNS3355, Lot Number 2022030790; MNS3355, Lot Number 2022071590; MNS3355, Lot Number 2022080590; MNS3355, Lot Number 2022101490; MNS3355, Lot Number 2023021090; MNS3355, Lot Number 2023053090; MNS3355, Lot Number 2023091390; MNS3355, Lot Number 2023121490; MNS10875, Lot Number 2019031590; MNS5575, Lot Number 2019061090; MNS5575, Lot Number 2020072090; MNS5575, Lot Number 2020081790; MNS10875A, Lot Number 2020081790; MNS10875A, Lot Number 2020090390; MNS5575, Lot Number 2020102390; MNS5575, Lot Number 2021012590; MNS10875A, Lot Number 2021012690; MNS10875A, Lot Number 2021031190; MNS10875A, Lot Number 2021051490; MNS10875A, Lot Number 2021072990; MNS10875A, Lot Number 2021102890; MNS10875A, Lot Number 2022031190; MNS10875A, Lot Number 2022061490; MNS10875A, Lot Number 2022091590; MNS10875A, Lot Number 2023040690; MNS10875A, Lot Number 2023092990; MNS10875A, Lot Number 2023110890; DYNDC1960A, Lot Number 2022010790; DYNDC2945, Lot Number 2023040690; EBSI1241, Lot Number 2021021190; SPEC0156A, Lot Number 2019100490; DYNDC2859A, Lot Number 2020081790; DYNDC2859A, Lot Number 2023053090; SUT9790, Lot Number 2020090390; SUT9790, Lot Number 2020113090; SUT4020, Lot Number 2021051490; SUT4020, Lot Number 2021072990; SUT4020, Lot Number 2022071590; DYNDL1422A, Lot Number 2019061090; UVT125, Lot Number 2023110890; MNS9580, Lot Number 2019100490; MNS9580, Lot Number 2022042890; MNS11020, Lot Number 2018103190; MNS11020, Lot Number 2019012390; MNS11020, Lot Number 2019041790; MNS11020A, Lot Number 2019080690; MNS11020A, Lot Number 2021021190; MNS11020A, Lot Number 2021030390; MNS11020A, Lot Number 2021041690; MNS11020A, Lot Number 2022042890

worldwide

Voluntary: Firm initiated