FDA Device recall Z-2984-2024
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894 by Medline Industries Northfield, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2984-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B ; 6) ENT TRACHEOTOMY , Pack Number DYNJ55523C ; 7) DR NIELSON THORACOSCOPY , Pack Number DYNJ61471A ; 8) TRACH PACK, Pack Number DYNJ64583; 9) TRACHEOSTOMY, Pack Number DYNJ902123G; 10) TRACHEOSTOMY, Pack Number DYNJ902123I; 11) TRACHEOSTOMY, Pack Number DYNJ902123J; 12) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525 ; 13) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525H; 14) BEDSIDE TRACHEOTOMY , Pack Number DYNJ909743
Reason
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.
Identifiers
| code_info | DYNDA1894, Lot Number 21HBD322 ; DYNDA1894, Lot Number 21HBF874 ; DYNDA1894, Lot Number 21IBL847 ; DYNDA1894, Lot Nu…DYNDA1894, Lot Number 21HBD322 ; DYNDA1894, Lot Number 21HBF874 ; DYNDA1894, Lot Number 21IBL847 ; DYNDA1894, Lot Number 21JBM308 ; DYNDA1894, Lot Number 21KBS529 ; DYNDA1894, Lot Number 19ABT326 ; DYNDA1894, Lot Number 22CBG860 ; DYNDA1894, Lot Number 19BBD317 ; DYNDA1894, Lot Number 19CBV464 ; DYNDA1894, Lot Number 22JBO787 ; DYNDA1894, Lot Number 23CBL463 ; DYNDA1894, Lot Number 23JBP440 ; DYNDA1894, Lot Number 23KBX335 ; DYNDA1894, Lot Number 20LBS038 ; DYNDA1894, Lot Number 21BBO392 ; DYNDA1894, Lot Number 24ABL991 ; DYNJ46518G , Lot Number 21KBO731 ; DYNJ46518G , Lot Number 21LBN631 ; DYNJ46518G , Lot Number 21LBN633 ; DYNJ50007A , Lot Number 19EBV606 ; DYNJ50007B , Lot Number 19VBF523 ; DYNJ50007B , Lot Number 19VBG533 ; DYNJ55523C , Lot Number 22BBB625 ; DYNJ55523C , Lot Number 22EBN464 ; DYNJ55523C , Lot Number 22FBX756 ; DYNJ55523C , Lot Number 23ABB987 ; DYNJ55523C , Lot Number 23BBR466 ; DYNJ55523C , Lot Number 23CBP129 ; DYNJ55523C , Lot Number |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2984-2024%22
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