| Class 1 Device Recall P5TEE | |
Date Initiated by Firm | August 21, 2024 |
Date Posted | September 27, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-3207-2024 |
Recall Event ID |
95239 |
Product Classification |
Set, tubing and support, ventilator (w harness) - Product Code BZO
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Product | Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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
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For Additional Information Contact | Sentec 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 |
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. 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 Commerce | 50,460 units |
Distribution | US: Nationwide
OUS: Israel Japan Russia Switzerland Canada Turkey |
Total Product Life Cycle | TPLC Device Report |
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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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