Recall Z-0637-2024 ยท CBK Ventilator, Continuous, Facility Use
Percussionaire Corporation
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
| Date | Jan 17, 2024 (initiated Dec 12, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | 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 Ser |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905234 | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES Percussionaire Corp., Jun 13, 1991 |