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Open, Classified

Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

FDA Recall Z-0693-2024 · Posted 2024-01-17

Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2023-03-28
Product Quantity195

Reason for Recall

Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.

Firm Action

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 [email protected] If you have any questions, contact the firm's Customer Service at [email protected] 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

Root Cause

Process control

Distribution Pattern

US: RI, CA, TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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