Transport Phasitron Breathing Kit (Percussionaire) – Pressure Output Risk (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Brand
Percussionaire Corporation
Lot Codes / Batch Numbers
UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930, WO06028
Products Sold
UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
Percussionaire Corporation is recalling High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CT, FL, GA, IL, IN, KS, LA, MI, MN, MO, NJ, NC, OH, OR, TN, TX, UT, VA
Page updated: Jan 10, 2026