Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRA...
FDA Device Recall #Z-2982-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-2982-2024 |
| 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) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DYND300015P; 5) Flexible LMA Pack with Syringe and Lube, Size 2, Pack Number DYND300020P; 6) Flexible LMA Pack with Syringe and Lube, Size 2.5, Pack Number DYND300025P; 7) Flexible LMA Pack with Syringe and Lube, Size 3, Pack Number DYND300030P; 8) Flexible LMA Pack with Syringe and Lube, Size 4, Pack Number DYND300040P; 9) Flexible LMA Pack with Syringe and Lube, Size 5, Pack Number DYND300050P; 10) TRACHEOSTOMY TRAY , Pack Number DYNDJ1061A ; 11) TRACHEOSTOMY , Pack Number DYNJ45495F
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
CDS983142B , Lot Number 19DBQ261 ; CDS983142B , Lot Number 19FBD886 ; CDS983142B , Lot Number 19KBJ083 ; CDS984376B , Lot Number 21HBJ875 ; CDS984376B , Lot Number 21JBJ731 ; CDS984376B , Lot Number 22DBM097 ; CDS984376B , Lot Number 22EBK349 ; CDS984376B , Lot Number 19EBI656 ; CDS984376B , Lot Number 22HBS594 ; CDS984376B , Lot Number 19SBG293 ; CDS984376B , Lot Number 19IBF800 ; CDS984376B , Lot Number 22LBA281 ; CDS984376B , Lot Number 23ABC499 ; CDS984376B , Lot Number 23ABE884 ; CDS984376B , Lot Number 19VBG331 ; CDS984376B , Lot Number 23BBS463 ; CDS984376B , Lot Number 20DBF949 ; CDS984376B , Lot Number 20EBU288 ; CDS984376B , Lot Number 20HBP449 ; CDS984376B , Lot Number 20IBM472 ; CDS984376B , Lot Number 21ABF587 ; DYND300010P, Lot Number 59220061157; DYND300010P, Lot Number 59220122559; DYND300010P, Lot Number 59221040752; DYND300010P, Lot Number 59221071480; DYND300010P, Lot Number 59222030363; DYND300010P, Lot Number 59222051032; DYND300010P, Lot Number 59222061222; DYND300010P, Lot Number 59222040781; DYND300010P, Lot Number 59222040997; DYND300010P, Lot Number 59222071481; DYND300010P, Lot Number 59222071537; DYND300015P, Lot Number 59220061157; DYND300015P, Lot Number 59220122559; DYND300015P, Lot Number 59221040651; DYND300015P, Lot Number 59221050988; DYND300015P, Lot Number 59221091941; DYND300015P, Lot Number 59222051078; DYND300015P, Lot Number 59222051032; DYND300015P, Lot Number 59222081778; DYND300015P, Lot Number 59222081923; DYND300020P, Lot Number 59220061157; DYND300020P, Lot Number 59221030489; DYND300020P, Lot Number 59221061255; DYND300020P, Lot Number 59221102224; DYND300020P, Lot Number 59221112515; DYND300020P, Lot Number 59221122696; DYND300020P, Lot Number 59222040997; DYND300020P, Lot Number 59222051032; DYND300020P, Lot Number 59222061222; DYND300020P, Lot Number 59222071643; DYND300020P, Lot Number 59222081908; DYND300020P, Lot Number 59222040781; DYND300020P, Lot Number 59222071481; DYND300020P, Lot Number 59222081778; DYND300020P, Lot Number 59222081923; DYND300025P, Lot Number 59220061157; DYND300025P, Lot Number 59221030489; DYND300025P, Lot Number 59221061255; DYND300025P, Lot Number 59221071480; DYND300025P, Lot Number 59222051032; DYND300025P, Lot Number 59222061222; DYND300025P, Lot Number 59222081908; DYND300025P, Lot Number 59222081778; DYND300025P, Lot Number 59222081923; DYND300030P, Lot Number 59220061157; DYND300030P, Lot Number 59221020196; DYND300030P, Lot Number 59221030489; DYND300030P, Lot Number 59221040752; DYND300030P, Lot Number 59221081720; DYND300030P, Lot Number 59222010094; DYND300030P, Lot Number 59222010145; DYND300030P, Lot Number 59222030363; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222051032; DYND300030P, Lot Number 59222061222; DYND300030P, Lot Number 59222071481; DYND300030P, Lot Number 59222071690; DYND300030P, Lot Number 59222081778; DYND300030P, Lot Number 59222081923; DYND300040P, Lot Number 59220061157; DYND300040P, Lot Number 59220122896; DYND300040P, Lot Number 59221030489; DYND300040P, Lot Number 59221050956; DYND300040P, Lot Number 59221061255; DYND300040P, Lot Number 59221061366; DYND300040P, Lot Number 59221071370; DYND300040P, Lot Number 59221071480; DYND300040P, Lot Number 59221071620; DYND300040P, Lot Number 59221050960; DYND300040P, Lot Number 59221061193; DYND300040P, Lot Number 59221081720; DYND300040P, Lot Number 59221102224; DYND300040P, Lot Number 59221112515; DYND300040P, Lot Number 59221112403; DYND300040P, Lot Number 59221122696; DYND300040P, Lot Number 59222030363; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222061222; DYND300040P, Lot Number 59222040781; DYND300040P, Lot Number 59222040923; DYND300040P, Lot Number 59222071481; DYND300040P, Lot Number 59222071690; DYND300040P, Lot Number 59222081778; DYND300040P, Lot Number 59222081923; DYND300050P, Lot Number 59220061157; DYND300050P, Lot Number 59220122559; DYND300050P, Lot Number 59220122896; DYND300050P, Lot Number 59221030489; DYND300050P, Lot Number 59221061255; DYND300050P, Lot Number 59221071370; DYND300050P, Lot Number 59221050956; DYND300050P, Lot Number 59221050960; DYND300050P, Lot Number 59221112515; DYND300050P, Lot Number 59221112403; DYND300050P, Lot Number 59221122696; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222051032; DYND300050P, Lot Number 59222061222; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222071690; DYND300050P, Lot Number 59222081778; DYND300050P, Lot Number 59222081923; DYNDJ1061A , Lot Number 21IBM637 ; DYNDJ1061A , Lot Number 21KBR259 ; DYNDJ1061A , Lot Number 19BBL149 ; DYNDJ1061A , Lot Number 22HBA163 ; DYNDJ1061A , Lot Number 22LBS593 ; DYNDJ1061A , Lot Number 23BBR453 ; DYNDJ1061A , Lot Number 20ABI199 ; DYNDJ1061A , Lot Number 20ABQ477 ; DYNDJ1061A , Lot Number 20BBV927 ; DYNDJ1061A , Lot Number 20CBZ583 ; DYNDJ1061A , Lot Number 23HBA926 ; DYNDJ1061A , Lot Number 23IBU987 ; DYNDJ1061A , Lot Number 23KBF024 ; DYNDJ1061A , Lot Number 23KBI637 ; DYNDJ1061A , Lot Number 20IBH461 ; DYNDJ1061A , Lot Number 20IBH534 ; DYNDJ1061A , Lot Number 20JBU615 ; DYNJ45495F , Lot Number 21DME648
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.