VentStar Bag Set (N) 110, MP00383

FDA device recall Z-1450-2023 · posted 2023-05-17 · Terminated

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

BTC

Quantity affected

375 units

Distribution

Domestic: US Nationwide Distribution.

Date initiated

2023-04-17

Date posted

2023-05-17

Date terminated

2024-09-03

Location

Telford, PA