SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Check against the official notice below — it lists the full affected range.
ConvaTec, Inc. is recalling 600 market units of SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) due to skin barrier delamination issues and tape border defects. The company received 10 complaints involving problems such as the flange lifting from the wafer, separation of skin barrier layers, and rips or tears in the tape border. The affected product has lot number 1H02899 with an expiration date of August 2026 and was distributed nationwide across 20 states as well as internationally to India.
The recall affects product order number ICC 413157 (DI Number 00768455106189). The affected states include New Jersey, Pennsylvania, Ohio, California, Alabama, Michigan, New York, Texas, Florida, North Carolina, Virginia, Louisiana, Illinois, Delaware, Kentucky, Washington, Kansas, Minnesota, and Mississippi. The source document does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Reason for recall: Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears. Distribution: Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India. Quantity: 600 market units Lot/code info: Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.