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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile CoFlex NL

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  Class 2 Device Recall Sterile CoFlex NL see related information
Date Initiated by Firm April 02, 2024
Date Posted May 15, 2024
Recall Status1 Open3, Classified
Recall Number Z-1828-2024
Recall Event ID 94394
Product Classification Bandage, elastic - Product Code FQM
Product Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Code Information Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
Recalling Firm/
Manufacturer		 Andover Healthcare Inc.
9 Fanaras Dr
Salisbury MA 01952-1444
For Additional Information Contact Betsy Sikma
864-909-7908
Manufacturer Reason
for Recall		 A packaging seal gap could impact the sterility of the product.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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