Device recall
In-Line Valve, Product Number: P5-TEE
- Recall number
- Z-3320-2026
- Event id
- 99617
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Percussionaire Corporation
- Report date
- Oct 7, 2026
- Posted
- Sep 28, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Sep 28, 2026
- Product code
- MOD
- Device type
- Accessory To Continuous Ventilator (Respirator)
- Reason
- Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
- Root cause
- Device Design
- Quantity
- 98,434
- Code info
- UDI: 00849436000723
- Distribution
- Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Sandpoint, ID, United States