FDA recall Z-1828-2024

Andover Healthcare Inc. · Class II · device

Product

Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)

Reason for recall

A packaging seal gap could impact the sterility of the product.

Distribution

US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.

Key facts

Status
Ongoing
Initiation date
2024-04-02
Report date
2024-05-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salisbury, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1828-2024