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Devices
Device Recall RETINA PACK
Model / Serial
Code:9001611 Lots: 141015771 exp. 8/30/18 141216412 exp. 12/31/15 150116994 exp. 2/28/16 150418309 exp. 4/30/16 150619176 exp. 6/30/16
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Only in Puerto Rico.
Product Description
RETINA PACK 7/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 RETINA PACK
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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
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