High Frequency Transport Phasitron Breathing Circuit Kit… recallZ-0637-2024 · Percussionaire Corporation · initiated Dec 12, 2023
Class I Open, Classified All recalls posted in January 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Percussionaire Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process control
What the company is doing
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 ([email protected]) 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 ([email protected]) or FDA s MedWatch Adverse Event reporting program either online or by regular mail or fax.
Recall details
- Recall number
- Z-0637-2024
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Dec 12, 2023
- Posted by the FDA
- Jan 17, 2024
- Recalling firm
- Percussionaire Corporation
- Quantity
- 2145 units
- Product code
- CBK
- FDA submissions
- K905234
- 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
Product description
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Code information (models, lots, serial numbers)
UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Percussionaire A50605-DPercussionaire Corporation · Ventilator, Continuous, Facility Use1 recall5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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