Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245...
FDA Device Recall #Z-2767-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-2767-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
Product Description
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
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.
Distribution Pattern
worldwide
Lot / Code Information
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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.