Reported Mar 30, 2022 · Terminated
DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual…
Dignitana, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dignitana, Inc. · 10925 Estate Ln Ste W185 · Dallas, TX · 75238-2315
Is this the product you have?
- DigniCap Delta Scalp Cooling System
- Product Number900-1001
- LabelingThe DigniCap
- Scalp Cooling System User Manual (PN0P1DDCD01M-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
- Lot codes and dates
- All
- manufactured units lots/serial numbersA65860-A73244
- Amount recalled
- 499 dignicaps
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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