Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Recall
- Recall Number
- Z-3207-2024
- Event Number
- 95239
- Firm
- Percussionaire Corporation
- FEI Number
- 1000524541
- Product Code
- BZO
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- August 21, 2024
- Posted
- September 27, 2024
- Address
- 130 Mcghee Rd, Ste 109, Sandpoint, ID, 83864-8409
Description
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
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. Communicate and train with newly presented instructions for proper use to primary users of IPV therapy, specifically for in-line use. 5. Review institutional protocols related to P5-TEE inline use and update as needed to conform with the updated instructions. 6. Re-label current product by placing the sticker provided by Percussionaire on each individual P5-TEE bag on stock (stickers to be provided via mail). 7. Report any adverse events to [email protected] and/or to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 8. Report any quality problems experienced with the use of this product to Percussionaire/Sentec Customer Service department via email to [email protected].
US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
50,460 units