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Devices
Device Recall GOWN COOL IMPEV. XLGE BREATHABLE
Model / Serial
Code:9002592 Lots: 140915320 exp. 9/30/19 150116795 exp. 3/31/16 150217395 exp. 3/31/16 150317646 exp. 3/31/16 150317849 exp. 5/31/16 150317850 exp. 5/31/16 150317848 exp. 5/31/16 150418378 exp. 6/30/16
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Only in Puerto Rico.
Product Description
GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED || 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 GOWN COOL IMPEV. XLGE BREATHABLE
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Manufacturer
Customed, Inc
Manufacturer Address
Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
Manufacturer Parent Company (2017)
Customed Inc
Source
USFDA
Language
English
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