Device 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.
Z-0525-2018
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 78507
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,630 units (4,763 market units, 10 per pack)
- Official record key
device-enforcement:Z-0525-2018
Official wording
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).
Code information: Lot 7H02242
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
incorrectly labeled