Z-1828-2024 Class II Ongoing

Recalled by Andover Healthcare Inc. — Salisbury, MA

Recall Details

Product Type
Devices
Report Date
May 22, 2024
Initiation Date
April 2, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
108 cases (1,944 individual product packages)

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.

Distribution Pattern

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

Code Information

Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.