Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Class I - DangerousWhat Should You Do?
- Check if you have this product: No UDI/ Lots: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Percussionaire Corporation
- Reason for Recall:
- Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Product Codes/Lot Numbers:
No UDI/ Lots: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3207-2024
Related Recalls
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.