FDA recall Z-2984-2024

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 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

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2984-2024