Devices

Device Recall Elutia Surgical Wound Drain

Model / Serial
19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to one foreign consignee in Lebanon.
Product Description
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" || Two different sizes, 10 units per box: || 19 Fr Round Hubless part number 7110; || 24 Fr Round Hubless part number 7118. || AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
Manufacturer
Bacterin International, Inc.
1 Event
- Recall of Device Recall Elutia Surgical Wound Drain

Manufacturer

Bacterin International, Inc.

Manufacturer Address
Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
Manufacturer Parent Company (2017)
Xtant Medical Holdings, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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