Home / Recalls / Andover Healthcare Inc. / Z-1828-2024

Z-1828-2024 Class II Ongoing

Recalled by Andover Healthcare Inc. — Salisbury, MA

FDA device recall Z-1828-2024 was initiated by Andover Healthcare Inc. on April 2, 2024 and is designated Class II. Reason for recall: A packaging seal gap could impact the sterility of the product. The recall status is ongoing. Affected quantity: 108 cases (1,944 individual product packages).

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.

Other recalls by Andover Healthcare Inc.

Z-0182-2020 Class II — Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)
Z-0184-2020 Class II — Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)
Z-0179-2020 Class II — Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or co (June 19, 2019)
Z-0180-2020 Class II — Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or co (June 19, 2019)
Z-0183-2020 Class II — Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)
Z-0181-2020 Class II — Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)