Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC IN...
FDA Device Recall #Z-3010-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-3010-2024 |
| 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
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number DYNJ45882A ; 6) TONSIL PACK CATH, Pack Number DYNJ65199A ; 7) CATH PLACEMENT RIB FRACTURE , Pack Number DYNJ66475B ; 8) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211C ; 9) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211CH; 10) UROLOGY PK, Pack Number DYNJ80252C ; 11) PORT INSERTION PACK , Pack Number DYNJ81597
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 distribution.
Lot / Code Information
CVI4720A , Lot Number 23DLA715 ; CVI4720A , Lot Number 23ELB184 ; CVI4720A , Lot Number 23GLA187 ; CVI4720A , Lot Number 23ILA599 ; CVI4720A , Lot Number 23ILA949 ; CVI4720A , Lot Number 23JLA318 ; CVI4720A , Lot Number 23JLB102 ; CVI4720AH, Lot Number 23DLA715 ; CVI4720AH, Lot Number 23ELB184 ; CVI4720AH, Lot Number 23GLA187 ; CVI4720AH, Lot Number 23ILA599 ; CVI4720AH, Lot Number 23ILA949 ; CVI4720AH, Lot Number 23JLA318 ; CVI4720AH, Lot Number 23JLB102 ; CVI4880, Lot Number 22LBM567 ; CVI4880, Lot Number 23HBU762 ; DYNJ17634D , Lot Number 23LBB611 ; DYNJ45882A , Lot Number 21HBE710 ; DYNJ45882A , Lot Number 21HBO631 ; DYNJ45882A , Lot Number 21JBD536 ; DYNJ45882A , Lot Number 21VBB891 ; DYNJ45882A , Lot Number 22ABC436 ; DYNJ45882A , Lot Number 19ABG982 ; DYNJ45882A , Lot Number 22CBJ819 ; DYNJ45882A , Lot Number 19BBO164 ; DYNJ45882A , Lot Number 19PBB128 ; DYNJ45882A , Lot Number 19EBS629 ; DYNJ45882A , Lot Number 22GBT307 ; DYNJ45882A , Lot Number 19GBY671 ; DYNJ45882A , Lot Number 19HBJ848 ; DYNJ45882A , Lot Number 19HBZ560 ; DYNJ45882A , Lot Number 22KBA300 ; DYNJ45882A , Lot Number 19IBZ258 ; DYNJ45882A , Lot Number 23ABE331 ; DYNJ45882A , Lot Number 20ABD585 ; DYNJ45882A , Lot Number 23DBJ543 ; DYNJ45882A , Lot Number 20ABG271 ; DYNJ45882A , Lot Number 23FBT108 ; DYNJ45882A , Lot Number 23HBC860 ; DYNJ45882A , Lot Number 20GBJ357 ; DYNJ45882A , Lot Number 20HBL822 ; DYNJ45882A , Lot Number 20IBA668 ; DYNJ45882A , Lot Number 20IBC738 ; DYNJ45882A , Lot Number 20KBE707 ; DYNJ45882A , Lot Number 20KBO720 ; DYNJ45882A , Lot Number 20LBY802 ; DYNJ45882A , Lot Number 21CBX085 ; DYNJ65199A , Lot Number 22CBF155 ; DYNJ65199A , Lot Number 22EME843 ; DYNJ65199A , Lot Number 22EME844 ; DYNJ65199A , Lot Number 23AMH680 ; DYNJ65199A , Lot Number 23DMF610 ; DYNJ65199A , Lot Number 23GMA525 ; DYNJ65199A , Lot Number 23HMA956 ; DYNJ65199A , Lot Number 23HMI132 ; DYNJ66475B , Lot Number 22GBM321 ; DYNJ80211C , Lot Number 23GBJ521 ; DYNJ80211C , Lot Number 23GBT960 ; DYNJ80211C , Lot Number 23HBG313 ; DYNJ80211C , Lot Number 23JBQ875 ; DYNJ80211C , Lot Number 23KBM933 ; DYNJ80211C , Lot Number 23LBP433 ; DYNJ80211CH, Lot Number 23GBJ521 ; DYNJ80211CH, Lot Number 23GBT960 ; DYNJ80211CH, Lot Number 23HBG313 ; DYNJ80211CH, Lot Number 23JBQ875 ; DYNJ80211CH, Lot Number 23KBM933 ; DYNJ80211CH, Lot Number 23LBP433 ; DYNJ80252C , Lot Number 23FBM038 ; DYNJ81597, Lot Number 22IBF254 ; DYNJ81597, Lot Number 23BBO299 ; DYNJ81597, Lot Number 23EBW966 ; DYNJ81597, Lot Number 23JBR560 ; DYNJ81597, Lot Number 24ABD028
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.