Recall Z-2224-2021

Reason for recall

Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier

FDA-determined cause: Process change control

Action taken

Integra notified consignees (Hospitals, Government facilities, and Distributors) by letter via FedX 2 Day Mail on June 1, 2021 and email to Distributor. Letter states reason for recall, health risk and action to take: We request that you take the following actions: 1. Customers a. If you do have units of the affected product listed in Table 1, remove it immediately from service. b. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. c. If you do not have affected product, check the box, I do not have affected product. d. Complete the attached Acknowledgement Form and return to FCA2@integralife.com or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. A replacement order will also be placed for the quantity noted on the form. 2. Distributors a. If you do have the affected product listed in Table 1, remove the product from further distribution. b. Complete the attached form. If you do not have affected product, check the box, I do not have affected product. c. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have. d. Complete the attached Acknowledgement Form and return to FCA2@integralife.com or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. Please check your customer traceability records for shipments of above catalog numbers. g. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. h. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will co