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U.S. Department of Health and Human Services

Class 3 Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm)

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  Class 3 Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm) see related information
Date Initiated by Firm June 22, 2011
Date Posted October 05, 2011
Recall Status1 Terminated 3 on January 11, 2012
Recall Number Z-0013-2012
Recall Event ID 59952
Product Classification Collector, ostomy - Product Code EXB
Product Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm)

Required for application to a patient immediately after ostomy surgery.
Code Information Lot 1C00776 No 510K since this is Class I exempt.
Recalling Firm/
Convatec Inc.
200 Headquarters Park Drive
Skillman NJ 08558-2600
For Additional Information Contact Ms. Barbara DeLade
Manufacturer Reason
for Recall
Post-operative kits 57 mm may contain 70 mm pouches.
FDA Determined
Cause 2
Labeling mix-ups
Action The firm, ConvaTec, sent a "MEDICAL DEVICE RECALL" letter dated June 22, 2011 via UPS 2nd day air to all customers and sales representatives that received product. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop distributing and quarantine the recalled lot; perform a count of recalled product currently in inventory; complete and return the Recall Response Form via fax to (908) 904-2120 or mail to 200 Headquarters Park Drive, Skillman, New Jersey 08558; return the Recall Response Form even if no recalled product is in inventory; call the toll free number 1-800-582-6514 for return instructions and RGA number-(recall product must be returned in a separate container from any other product returns); mark all return shipments "Recalled Product" and provide supplied RGA number, and forward this letter to customers, if they distributed the product. Should you have any questions, call 1-800-582-6514.
Quantity in Commerce 283 units
Distribution Nationwide distribution: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX and UT.
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.