MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-2767-2024)

Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 6) BIOPSY TRAY, Pack Number BT1060; 7) BIOPSY TRAY, Pack Number BT1015; 8) BIOPSY TRAY, Pack Number DYNDH1137C; 9) BIOPSY TRAY-LF, Pack Number SPEC4380; 10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 11) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 13) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 14) CIRCUMCISION TRAY, Pack Number CIT7050C; 15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860; 17) ER CHEST TUBE TRAY, Pack Number CHT1570A; 18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 21) LUMBAR PUNCTURE TRAY, Pack Number PT215; 22) LUMBAR TRAY, Pack Number SPEC0197B; 23) NICU PICC KIT, Pack Number CVI4575; 24) OB DELIVERY TRAY, Pack Number MNS10875A; 25) ON/OFF KIT, Pack Number DT8525; 26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910; 28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 29) PORT ACCESS KIT, Pack Number DYNDC2945; 30) PORT ACCESS TRAY, Pack Number EBSI1241; 31) PORT INSERTION KIT, Pack Number MNS11590; 32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 33) STEREOTACTIC TRAY, Pack Number MNS5785; 34) SUTURING SET, Pack Number SUT4020; 35) U.A.C. TRAY, Pack Number UVT125; 36) ULTRASOUND TRAY, Pack Number MNS5460; 37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080; 38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 39) 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.

ART245C, Lot Number 2023101990; ART1170, Lot Number 2022121990; ART1170, Lot Number 2023012790; ART1170, Lot Number 2023021590; PT220, Lot Number 2021061490; PT220, Lot Number 2022011090; MNS12670A, Lot Number 2021060190; MNS12670A, Lot Number 2022011090; MNS12670A, Lot Number 2023022190; MNS12670A, Lot Number 2023101890; SUT20455, Lot Number 2021060190; SUT20455, Lot Number 2022011090; SUT20455, Lot Number 2023012390; BT1060, Lot Number 2020062490; BT1015, Lot Number 2021060190; DYNDH1137C, Lot Number 2021091490; DYNDH1137C, Lot Number 2022121990; SPEC4380, Lot Number 2018102950; SPEC4380, Lot Number 2023032390; DYNJTS0214, Lot Number 2022061790; DYNJTS0214, Lot Number 22121990; SPEC0130C, Lot Number 2023022190; S5078BF09, Lot Number 2020051850; S5078BF09, Lot Number 2022092290; CHT560, Lot Number 2018042790; CHT560, Lot Number 2018050790; CHT560, Lot Number 2018060490; CHT560, Lot Number 2018080790; CHT560, Lot Number 2018091190; CHT560, Lot Number 2020032490; CHT560, Lot Number 2020051990; CHT560, Lot Number 2020062490; CHT560, Lot Number 2020070190; CHT560, Lot Number 2020071490; CHT560, Lot Number 2020121590; CHT560, Lot Number 2021042690; CHT560, Lot Number 2021082390; CHT560, Lot Number 2021091490; CHT560, Lot Number 2022022490; CHT560, Lot Number 2022050490; CIT7050C, Lot Number 2023081480; CIT7050C, Lot Number 2023101680; CIT7050C, Lot Number 2024010590; DYNJ05162, Lot Number 2020082050; ECVC7860, Lot Number 2023101990; CHT1570A, Lot Number 2021051290; MNS12150, Lot Number 2019082790; MNS12150, Lot Number 2020021290; MNS12150, Lot Number 2020060290; MNS12150, Lot Number 2020101390; MNS12150, Lot Number 2020111790; MNS12150, Lot Number 2020121890; MNS12150, Lot Number 2021051290; MNS12150, Lot Number 2021071390; MNS12150, Lot Number 2022012890; MNS12150, Lot Number 2022061790; MNS12150, Lot Number 2022092290; MNS12150, Lot Number 2023010690; MNS12150, Lot Number 2023030690; MNS12150, Lot Number 2023082490; DYNDH1297, Lot Number 2019091750; DYNDH1406, Lot Number 2023102790; PT215, Lot Number 2018050350; PT215, Lot Number 2018100950; PT215, Lot Number 2018102950; PT215, Lot Number 2019091750; PT215, Lot Number 2019100450; PT215, Lot Number 2020051850; PT215, Lot Number 2020082050; PT215, Lot Number 2020102850; PT215, Lot Number 2020121550; PT215, Lot Number 2021021850; PT215, Lot Number 2021111850; PT215, Lot Number 2022021650; PT215, Lot Number 2022043050; PT215, Lot Number 2022072990; PT215, Lot Number 2023012390; PT215, Lot Number 2023032790; PT215, Lot Number 2023102790; PT215, Lot Number 2023122090; SPEC0197B, Lot Number 2018102950; CVI4575, Lot Number 2023102590; CVI4575, Lot Number 2023120190; MNS10875A, Lot Number 2021060190; DT8525, Lot Number 2023070590; DT8525, Lot Number 2023092890; DT8525, Lot Number 2024022090; IVS3320, Lot Number 2021061490; DYNDH1910, Lot Number 2023120480; MNS3560, Lot Number 2021091490; DYNDC2945, Lot Number 2023062190; EBSI1241, Lot Number 2021051290; MNS11590, Lot Number 2019072590; MNS11590, Lot Number 2021010690; MNS11590, Lot Number 2021061490; MNS11590, Lot Number 2021122190; MNS11590, Lot Number 2022050490; MNS11590, Lot Number 2023032390; MNS11590, Lot Number 2023062190; MNS11590, Lot Number 2023101990; DYNDC2859A, Lot Number 2021082390; MNS5785, Lot Number 2023032290; MNS5785, Lot Number 2023090590; MNS5785, Lot Number 2023120790; MNS5785, Lot Number 2024030690; SUT4020, Lot Number 2020051990; SUT4020, Lot Number 2020062490; UVT125, Lot Number 2021082390; MNS5460, Lot Number 2020051990; UVT1080, Lot Number 2022121990; UVT1080, Lot Number 2023090590; UVT1100A, Lot Number 2022050280; UVT1100A, Lot Number 2023011680; UVT1100A, Lot Number 2023041780; UVT1100A, Lot Number 2023061980; UVT1100A, Lot Number 2023101680; UVT1100A, Lot Number 2023120480; UVT1100A, Lot Number 2024011580; MNS11020A, Lot Number 2021060190

worldwide

Voluntary: Firm initiated