Recall Z-3207-2024 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
| Date | Sep 27, 2024 (initiated Aug 21, 2024) |
| Status | Open, Classified |
| Reason | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. |
| Root cause | Device Design |
| Action | On September 3, 2024, Percussionaire Inc. issued a "Urgent Medical Device Field Safety Notice" to affected consignees. Percussionaire asked consignees to take the following actions: 1. Complete and Return Acknowledgement form (see Appendix 1) after reviewing and implementing the requested actions below by September 27, 2024. 2. Review updated instructions for proper in-line use (see Appendix 3) and updated IFU (see Appendix 4) 3. Print and post updated instructions for proper In-Line Valve use (Appendix 3) throughout your facility for adequate distribution of new information to users. 4. C |
| Quantity | 50,460 units |
| Distribution | US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.