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U.S. Department of Health and Human Services

Class 1 Device Recall P5TEE20

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 Class 1 Device Recall P5TEE20see related information
Date Initiated by FirmAugust 21, 2024
Date PostedSeptember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3208-2024
Recall Event ID 95239
Product Classification Set, tubing and support, ventilator (w harness) - Product Code BZO
ProductPercussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Code Information 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
Recalling Firm/
Manufacturer		 Percussionaire Corporation
130 Mcghee Rd Ste 109
Sandpoint ID 83864-8409
For Additional Information ContactSentec Customer Service
1877-425-8746
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce2523 units
DistributionUS: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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