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Devices
Device Recall Custom Spinal Anesthesia Tray
Model / Serial
Catalog Number: 560399 (Lot # 0061418559, 0061422389, 0061434523, 0061438084, 0061440188, 0061446168, 0061450971, 0061459227, 0061464239, Catalog Number: 560511 (Lot # 0061413435, 0061425996, 0061438393, 0061452272, 0061465310), Catalog # 560605 (0061420240, 0061429962, 0061442280, 0061449510, 0061460497, 0061471580), Catalog # 560631 (Lot# 0061438803), Catalog # 560632 (0061438818).
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution to: AL, IL, OK, MN, MA and WI.
Product Description
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) || Injection of anesthetics to provide regional anesthesia
Manufacturer
B. Braun Medical, Inc.
1 Event
Recall of Device Recall Custom Spinal Anesthesia Tray
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Manufacturer
B. Braun Medical, Inc.
Manufacturer Address
B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
Manufacturer Parent Company (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
Language
English
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