| Class 2 Device Recall SURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar |  |
Date Initiated by Firm | October 26, 2017 |
Create Date | February 05, 2018 |
Recall Status1 |
Terminated 3 on February 03, 2023 |
Recall Number | Z-0525-2018 |
Recall Event ID |
78507 |
Product Classification |
Ostomy care kit - Product Code PQE
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Product | SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802.
Intended for use as an ostomy protector providing a protective barrier to patient skin. |
Code Information |
Lot 7H02242 |
Recalling Firm/ Manufacturer |
ConvaTec, Inc 7900 Triad Center Dr Ste 400 Greensboro NC 27409-9076
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For Additional Information Contact | 336-547-3730 |
Manufacturer Reason for Recall | A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive
Skin Barrier (10 pack, 45 mm, REF 411803). |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | Customers were notified of the recall via Urgent: Voluntary Medical Device Recall letters on approximately 10/26/2017. The letter identified the affected device and the reason for the recall. The letter also provided instructions for distributors, retailers, and end users. End Users are to 1.) Inspect all shippers of 411802 (Durahesive), and all loose market units of 411803 (Stomahesive) to confirm whether affected product is under their control; 2.) Perform a count of affected product currently in inventory and complete and return the enclosed response form to the address provided; 3.) If customers have any affected product in inventory they are to contact cic@convatec.com or call the Customer Interaction Center at the toll free number 1-800-422-8811 for further instructions regarding how to return affected product and receive correctly labeled replacement product. |
Quantity in Commerce | 47,630 units (4,763 market units, 10 per pack) |
Distribution | Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI. |
Total Product Life Cycle | TPLC Device Report |
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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.
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