Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2984-2024
• Recall Event ID: 94583
• Product Classification: Tracheotomy care kit - Product Code NXA
• 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
• 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
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.