Z-0525-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- October 26, 2017
- Termination Date
- February 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,630 units (4,763 market units, 10 per pack)
Product Description
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.
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).
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.
Code Information
Lot 7H02242