Recall Z-0525-2018 ยท PQE Ostomy Care Kit
ConvaTec, Inc
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.
| Date | Oct 26, 2017 |
| Status | Terminated |
| Reason | 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). |
| Root cause | 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.) I |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.