Date Initiated by Firm | April 17, 2023 |
Date Posted | May 17, 2023 |
Recall Status1 |
Terminated 3 on September 03, 2024 |
Recall Number | Z-1445-2023 |
Recall Event ID |
92049 |
Product Classification |
Bag, reservoir - Product Code BTC
|
Product | VentStar breathing bag Set (P) 110, MP00384 |
Code Information |
UDI-DI: 04048675421870; All lots. |
Recalling Firm/ Manufacturer |
Draeger Medical, Inc. 3135 Quarry Rd Telford PA 18969-1042
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For Additional Information Contact | Michael Kelhart 215-660-2349 |
Manufacturer Reason for Recall | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
FDA Determined Cause 2 | Process control |
Action | The firm distributed recall notifications to consignees via FedEx starting on 4/17/2023. Consignees are instructed to immediately stop use of affected devices, inspect current stock, and quarantine any affected devices to prevent use. Alternative therapy for patients should be instituted as soon as possible and ensure all users of affected devices within consignee organizations are aware of the recall, with copies being forwarded if devices were further distributed. To replace or return unused products, consignees are to call Draeger Customer Success between 8:00 AM - 6:00 PM EST, Monday thru Friday, at 1-800-437-2437 (option 2, then option 1), or via email at US-Medical@draeger.com. A Return Materials Authorization and pre-paid shipping label will be provided upon request. Any additional questions regarding the recall communication may be directed to Mr. Michael Kelhart between the hours of 8:00 AM - 4:30 PM by phone at 267-664-1131 or by email at mike.kelhart@draeger.com. |
Quantity in Commerce | 25 units |
Distribution | Domestic: US Nationwide Distribution. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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