FDA recall Z-0926-2025

Product

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Distribution

Domestic: Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2024-12-03

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0926-2025