Dignitana, Inc. recalls DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual…

Recall date

November 5, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0825-2022

FDA classification

Class II

Brand / firm

Dignitana, Inc.

Sold / distributed

US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.

Why it was recalled

Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,