Z-2984-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 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.
Code Information
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 23EBW287 ; DYNJ55523C , Lot Number 23HBO179 ; DYNJ55523C , Lot Number 23JBN656 ; DYNJ61471A , Lot Number 21HBE324 ; DYNJ61471A , Lot Number 21LBO974 ; DYNJ61471A , Lot Number 22BBY429 ; DYNJ61471A , Lot Number 22DBQ350 ; DYNJ61471A , Lot Number 22LBJ146 ; DYNJ61471A , Lot Number 23CBP132 ; DYNJ61471A , Lot Number 23IBE187 ; DYNJ61471A , Lot Number 23KBB186 ; DYNJ64583, Lot Number 21IBC649 ; DYNJ64583, Lot Number 21IBJ828 ; DYNJ64583, Lot Number 21IBS979 ; DYNJ64583, Lot Number 22GBO053 ; DYNJ64583, Lot Number 22LBB121 ; DYNJ64583, Lot Number 19KBI997 ; DYNJ64583, Lot Number 23FBA258 ; DYNJ64583, Lot Number 23KBV611 ; DYNJ64583, Lot Number 24ABM408 ; DYNJ909525 , Lot Number 23EBJ496 ; DYNJ909525 , Lot Number 23HBH829 ; DYNJ909525 , Lot Number 23IBD159 ; DYNJ909525 , Lot Number 23LBF615 ; DYNJ902123G, Lot Number 21FDB495 ; DYNJ902123G, Lot Number 21HDA217 ; DYNJ902123G, Lot Number 21KDA143 ; DYNJ902123G, Lot Number 21LDA525 ; DYNJ902123G, Lot Number 22CDB069 ; DYNJ902123G, Lot Number 22GDB802 ; DYNJ902123G, Lot Number 22HDA871 ; DYNJ902123G, Lot Number 23ADB623 ; DYNJ902123G, Lot Number 23BDA748 ; DYNJ902123I, Lot Number 23HDB751 ; DYNJ902123I, Lot Number 23IDB087 ; DYNJ902123J, Lot Number 23JDB498 ; DYNJ902123J, Lot Number 24BDB737 ; DYNJ45495G , Lot Number 21HMG197 ; DYNJ45495G , Lot Number 21IMB564 ; DYNJ45495G , Lot Number 21KMB040 ; DYNJ45495G , Lot Number 22DMC103 ; DYNJ45495G , Lot Number 22FMC965 ; DYNJ45495G , Lot Number 22IMI120 ; DYNJ45495G , Lot Number 23AME356 ; DYNJ45495G , Lot Number 23BMA551 ; DYNJ45495G , Lot Number 23DMC990 ; DYNJ45495G , Lot Number 23IMF939 ; DYNJ45495G , Lot Number 23KME498 ; DYNJ45495G , Lot Number 23LMB979 ; DYNJ45495G , Lot Number 24AMA042 ; DYNJ46518G , Lot Number 22EMG387 ; DYNJ46518G , Lot Number 22HMD287 ; DYNJ46518G , Lot Number 22JMA904 ; DYNJ46518G , Lot Number 22JMB321 ; DYNJ46518G , Lot Number 23BMC141 ; DYNJ46518G , Lot Number 23CMD470 ; DYNJ46518G , Lot Number 23DME173 ; DYNJ46518G , Lot Number 23FMA265 ; DYNJ909743 , Lot Number 23KLA140 ; DYNJ909743 , Lot Number 23KLA204 ; DYNJ909525H, Lot Number 23EBJ496 ; DYNJ909525H, Lot Number 23HBH829 ; DYNJ909525H, Lot Number 23IBD159 ; DYNJ909525H, Lot Number 23LBF615