FDA recall Z-0520-2024

Product

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Reason for recall

Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

Distribution

Nationwide Foreign: Italy

Key facts

Status

Ongoing

Initiation date

2023-10-19

Report date

2023-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0520-2024