Z-0825-2022 Class II Terminated
FDA device recall Z-0825-2022 was initiated by Dignitana, Inc. on November 5, 2021 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated October 29, 2024). Affected quantity: 499 dignicaps.
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2022
- Initiation Date
- November 5, 2021
- Termination Date
- October 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 499 dignicaps
Product Description
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,
Reason for Recall
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.
Distribution Pattern
US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.
Code Information
All manufactured units lots/serial numbers: A65860-A73244