Devices

Device Recall OPEN HEART PACK

Model / Serial
Code:9002618 Lots: 140915325 exp. 10/31/15 141015615 exp. 11/30/15 141216324 exp. 12/31/15 150418448 exp. 5/31/16 150116558 exp. 5/31/16 150116558 exp. 5/31/16 150418449 exp. 5/31/16
Product Classification
Cardiovascular Devices
Device Class
1
Implanted device?
No
Distribution
Distributed Only in Puerto Rico.
Product Description
OPEN HEART PACK 1/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
Manufacturer
Customed, Inc
1 Event
- Recall of Device Recall OPEN HEART PACK

Manufacturer

Customed, Inc

Manufacturer Address
Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
Manufacturer Parent Company (2017)
Customed 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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