PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 22, 2024 Initiated: April 2, 2024 #Z-1828-2024

Product Description

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.

Details

Recalling Firm
Andover Healthcare Inc.
Units Affected
108 cases (1,944 individual product packages)
Distribution
US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
Location
Salisbury, MA

Frequently Asked Questions

What product was recalled?
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S). Recalled by Andover Healthcare Inc.. Units affected: 108 cases (1,944 individual product packages).
Why was this product recalled?
A packaging seal gap could impact the sterility of the product.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1828-2024.