FDA recall Z-2750-2024

Product

Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179AH; 6) JSI-MUSCLE&PLASTICS PACK-LF , Pack Number DYNJ0608555P; 7) OCCULAR PLASTIC, Pack Number DYNJ901206F; 8) OCCULAR PLASTIC PACK, Pack Number CMPJ05506F; 9) OCCULOPLASTIC PACK, Pack Number DYNJ65156; 10) PLASTIC PACK, Pack Number DYNJ47842C;

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

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2750-2024