Class 3 Device Recall Natura Durahesive Convatec Moldable Techonology PostOperative/Surgical System (57mm)

• Date Initiated by Firm: February 01, 2011
• Date Posted: March 08, 2011
• Recall Status: Terminated on January 11, 2012
• Recall Number: Z-1610-2011
• Recall Event ID: 57936
• Product Classification: Collector, ostomy - Product Code EXB
• Product: Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch; This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.
• Code Information: Product Code # 416921; Product Lot # 0J00814
• Recalling Firm/ Manufacturer: Convatec Inc.; 200 Headquarters Park Drive; Skillman NJ 08558-2600
• For Additional Information Contact: Ms. Barbara DeLade; 908-904-2675
• Manufacturer Reason for Recall: Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together.
• FDA Determined Cause: Employee error
• Action: Convatec sent a Medical Device Recall letter dated February 1, 2011, via UPS with return response forms attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop distributing and quarantine the recalled lot (0100814). Perform a count of recalled product currently in inventory. Complete the enclosed Recall Response Form and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. Ensure that their account number is correctly identified on the attached Recall Response Form. To return the recalled product call the toll free number 1-800-582-6514 to receive an RGA number and instructions on how and where to return the recalled product. If the product has been distributed to wholesalers then customers should forward the letter to them and ask that they follow the Required Actions and return the Recall Response Form to the address listed on the form. Product must be labeled for shipment to: UPS Supply Chain Solutions 1920 Outer Loop Dock Door #123 Louisville, KY 40219 For questions regarding this recall call 908-904-2149.
• Quantity in Commerce: 77 market units
• Distribution: Nationwide Distribution including AZ, IL, KS, MA, MI, NC, OK, OR, PA, SC, and TX.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.