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Devices
Device Recall Disposable AEM Cord
Model / Serial
REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
Product Description
Encision ES4107 Disposable AEM Cord, Sterile.
Manufacturer
Encision, Inc.
1 Event
Recall of Device Recall Disposable AEM Cord
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Manufacturer
Encision, Inc.
Manufacturer Address
Encision, Inc., 4828 Sterling Dr, Boulder CO 80301-2350
Source
USFDA
Language
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