FDA recall Z-2982-2024

Product

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

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-2982-2024