FDA Medical Device Recalls (openFDA)
Andover Healthcare Inc.: Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
- Recall number
- Z-1828-2024
- Recalling firm
- Andover Healthcare Inc.
- Product
- Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
- Status
- Open, Classified
- Initiated
- 2024-04-02
- Posted
- 2024-05-15
- Terminated
- not on file
- Reason
- A packaging seal gap could impact the sterility of the product.
- Root cause
- Process control
- Action
- On April 2, 2024, customers were notified via phone, email and certified mail. Actions to be taken by customer/user: Please identify and return all cases of Batch 0031151359, Lot 10009897233 Sterile CoFlex NL, Tan, 4INx5YD (5400S) made January 2024, shipped February 2024 - March 2024. Please make sure everyone in your organization is fully aware of this corrective action and follows these instructions. 1. Please discontinue the distribution and use of Batch 0031151359, Lot 10009897233, Sterile CoFlex NL Tan 4INx5YD (5400S). 2. Please identify all customers that purchased inventory of Batch 0031151359, Lot 10009897233, Sterile CoFlex NL Tan 4INx5YD (5400S). Email the attached Customer Notice to each of those customers so that they can participate in the recall. If you have a physical address, please also mail them the attached Customer Notice. Retain written proof that the Customer Notice has been sent and received. We will reimburse you for your postage and shipping costs upon receipt of reasonable proof of those costs. If you would prefer for us to handle the communications to your customers, we will do so at no charge if you provide all available contact information. Refer to our contact information below for all questions and requests for reimbursement. 3. Please return all cases of Batch 0031151359, Lot 10009897233, Sterile CoFlex NL, Tan, 4INx5YD (5400S) to OVIK Health, LLC, c/o Customer Care, 9 Fanaras Drive, Salisbury, MA 01952. 4. Please phone or email your acknowledgement of this recall notice (using the attached Acknowledgement and Receipt Form or otherwise) to: Phone: 1 (800) 432-6686 (toll free), E-mail: customerservice@ovikhealth.com. Upon receipt of returned products, OVIK Health, LLC will issue a credit. We will continue to provide these products with minimal interruption in the supply chain. For further information, questions, or concerns please do not hesitate to reach out to OVIK Health, LLC at: Monday through Friday, 8:00 AM to 4:30 PM, Eas
- Quantity
- 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.
- Lot, serial or model codes
- Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQM
- Firm FEI
- 1220799
- Firm city
- Salisbury
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28