High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

FDA device recall Z-0637-2024 · posted 2024-01-17 · Open, Classified

Recall details

Recalling firm

Percussionaire Corporation

Reason for recall

Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user

Action taken

On January 17, 2024, Percussionaire issued a Urgent Medical Device Recall Notification Update via E-Mail to affected consignees to provide additional information. The original notification was issued on December 12, 2023. Percussionaire asked consignees to take the following actions: Customer Instructions 1. Complete and Return Acknowledgement form (attached). 2. Complete Pre-Check Checklist prior to patient use. 3. Prioritize the return of all impacted product. 4. Report any adverse reactions or quality problems experienced with the use of this product to Percussionaire/Sentec Customer Service department via email (customerservice.us@sentec.com) or FDA s MedWatch Adverse Event reporting program either online or by regular mail or fax. Distributor Instructions 1. Complete and Return Distributor Acknowledgement form (attached). 2. Send Urgent Field Safety Notice containing Pre-Use Checklist to end customers. 3. Prioritize the return of affected lots in stock. 4. Support end customers returning affected products. 5. Report any adverse reactions or quality problems experienced with the use of this product to Percussionaire/Sentec Customer Service department via email (customerservice.us@sentec.com) or FDA s MedWatch Adverse Event reporting program either online or by regular mail or fax.

Root cause

Process control

Status

Open, Classified

Product code

CBK

Quantity affected

2145 units

Distribution

US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None

Date initiated

2023-12-12

Date posted

2024-01-17

Location

Sandpoint, ID

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