SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Summary
The FDA issued a Class II for SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains by ConvaTec, Inc. Reason: Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Details
Source
Device Recall
External ID
Z-1134-2022
Action Date
2022-06-01
Status
Terminated
Category
device
Product Description
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Lot/Code Info: Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
Quantity Affected: 600 market units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-22
Company
Greensboro, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ConvaTec, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ConvaTec, Inc have FDA actions?
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1134-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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