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U.S. Department of Health and Human Services

Class 1 Device Recall High Frequency Transport Phasitron Breathing Circuit Kit

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  Class 1 Device Recall High Frequency Transport Phasitron Breathing Circuit Kit see related information
Date Initiated by Firm December 12, 2023
Date Posted January 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-0637-2024
Recall Event ID 93476
510(K)Number K905234  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Code Information UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
Recalling Firm/
Manufacturer		 Percussionaire Corporation
130 Mcghee Rd Ste 109
Sandpoint ID 83864-8409
For Additional Information Contact Robert Cormier
208-263-2549
Manufacturer 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
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = PERCUSSIONAIRE CORP.
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