Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
- Company
- Percussionaire Corporation
- Recall Initiated
- March 28, 2023
- Posted
- January 17, 2024
- Recall Number
- Z-0693-2024
- Quantity
- 195
- Firm Location
- Sandpoint, ID
Reason for Recall
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Distribution
US: RI, CA, TX
Lot / Code Info
UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.
Root Cause
Process control
Action Taken
On 3/28/23, correction notices were emailed to customers who were asked to remove and switch the reservoir bag to the proper location. On 1/24/24, follow-up correction notices were sent to customers who were asked to do the following: 1) Review your inventory, and if affected devices are identified, ensure the reservoir bag is in the proper location. 2) If affected devices were further distributed, send a copy of this notice to your customers. 3) Complete and return the Effectiveness Check Questionnaire via email to customerservice.us@sentec.com If you have any questions, contact the firm's Customer Service at customerservice.us@sentec.com or by phone at (208)- 263- 2549 Monday - Friday from 7 AM to 3:30 PM (PST). Additional information for contact information can be found at www.sentec.com/contact