Devices

Device Recall Belzer UW & Waters IGL Cold Storage Solution

Model / Serial
UDI 00810805000163, and UDI 00810805000071.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA and Europe.
Product Description
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. || Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
Manufacturer
Preservation Solutions, Inc.
1 Event
- Recall of Device Recall Belzer UW & Waters IGL Cold Storage Solution

Manufacturer

Preservation Solutions, Inc.

Manufacturer Address
Preservation Solutions, Inc., 1099 Proctor Dr, Elkhorn WI 53121-2027
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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