Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
This recall is currently active, issued May 15, 2024. It was issued by Andover Healthcare Inc..
- Company
- Andover Healthcare Inc.
- Recall Initiated
- April 2, 2024
- Posted
- May 15, 2024
- Recall Number
- Z-1828-2024
- Quantity
- 108 cases (1,944 individual product packages)
- Firm Location
- Salisbury, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
Root Cause
Process control
Action Taken
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