Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
- Company
- Percussionaire Corporation
- Recall Initiated
- August 21, 2024
- Posted
- September 27, 2024
- Recall Number
- Z-3208-2024
- Quantity
- 2523 units
- Firm Location
- Sandpoint, ID
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.
Distribution
US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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 regulatory.percussionaire@sentec.com 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 FSCA@sentec.com.