FDAClass IINovember 9, 2016

Affected Pain Control Tray Component recall

Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional…

Why was Affected Pain Control Tray Component recalled?

B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional…
Recalling firm
B. Braun Medical, Inc.
Quantity
1704 units
Distribution
US Distribution to: AL, IL, OK, MN, MA and WI.
Recall date
November 9, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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