Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERT...
FDA Device Recall #Z-3015-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-3015-2024 |
| 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) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Number DYNJ66416; 6) DRAINAGE TRAY , Pack Number DYNJ68767; 7) INCISION AND DRAINAGE TRAY, Pack Number P737057
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
146255, Lot Number 23KBP730; 146255, Lot Number 23JBV770; 146255, Lot Number 23BBJ516; 146255, Lot Number 23ABS205; 146255, Lot Number 22LBQ260; 146255, Lot Number 22LBF150; CVI5080, Lot Number 24ABR654 ; CVI5080, Lot Number 24ABS414 ; DYNDA1063, Lot Number 21JBR507 ; DYNJ44599I , Lot Number 21FBO112 ; DYNJ44599I , Lot Number 21GBQ754 ; DYNJ44599I , Lot Number 21HBU200 ; DYNJ44599I , Lot Number 21KBM267 ; DYNJ44599I , Lot Number 21LBQ208 ; DYNJ44599I , Lot Number 22NBE952 ; DYNJ44599I , Lot Number 22EBA808 ; DYNJ44599I , Lot Number 22EBV387 ; DYNJ44599I , Lot Number 22GBL830 ; DYNJ44599I , Lot Number 22HBM625 ; DYNJ44599I , Lot Number 22IBN180 ; DYNJ44599I , Lot Number 22JBH998 ; DYNJ44599I , Lot Number 22JBX287 ; DYNJ44599I , Lot Number 23ABJ748 ; DYNJ44599I , Lot Number 23BBO863 ; DYNJ44599I , Lot Number 23CBU289 ; DYNJ44599I , Lot Number 23DBO841 ; DYNJ44599I , Lot Number 23EBP969 ; DYNJ44599I , Lot Number 23GBG623 ; DYNJ44599I , Lot Number 23HBR164 ; DYNJ44599I , Lot Number 20EBC852 ; DYNJ44599I , Lot Number 23IBU633 ; DYNJ44599I , Lot Number 20FBO439 ; DYNJ44599I , Lot Number 20GBA511 ; DYNJ44599I , Lot Number 23KBI875 ; DYNJ44599I , Lot Number 24ABA732 ; DYNJ44599I , Lot Number 20JBA956 ; DYNJ44599I , Lot Number 20JBZ002 ; DYNJ44599I , Lot Number 20KBD800 ; DYNJ44599I , Lot Number 20LBI387 ; DYNJ44599I , Lot Number 21CBN891 ; DYNJ44599I , Lot Number 21CBX162 ; DYNJ66416, Lot Number 20GKA807 ; DYNJ68767, Lot Number 21HLA622 ; DYNJ68767, Lot Number 21KLA137 ; DYNJ68767, Lot Number 21LLA666 ; DYNJ68767, Lot Number 22BLA542 ; DYNJ68767, Lot Number 22DLB131 ; DYNJ68767, Lot Number 22HLA449 ; DYNJ68767, Lot Number 22ILA208 ; DYNJ68767, Lot Number 22KLA881 ; DYNJ68767, Lot Number 23ALA469 ; DYNJ68767, Lot Number 23BLA292 ; DYNJ68767, Lot Number 23CLA817 ; DYNJ68767, Lot Number 23ELA407 ; DYNJ68767, Lot Number 23ELA587 ; DYNJ68767, Lot Number 23KLA248 ; DYNJ68767, Lot Number 23LLA473 ; P737057, Lot Number 21VBC482
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.