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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Spinal Anesthesia Tray

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  Class 2 Device Recall Custom Spinal Anesthesia Tray see related information
Date Initiated by Firm July 11, 2016
Date Posted November 01, 2016
Recall Status1 Terminated 3 on March 15, 2017
Recall Number Z-0327-2017
Recall Event ID 74879
Product Classification Tray, surgical - Product Code LRP
Product Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP)

Injection of anesthetics to provide regional anesthesia
Code Information 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).
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Customer Support Department
800-227-2862
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, B.Braun, mailed to customers a "VOLUNTARY DRUG RECALL NOTIFICATION" letter dated July 12, 2016. The letter described the product, problem and actions to be taken and to inform the customers of a drug recall issued by Hospira, Inc. The Customers were instructed to determine their current inventory of the affected lots Do not destroy any affected product), complete and return "Product Removal Acknowledgement" form via fax to: B.Braun Medical Inc., Quality Assurance department at (610) 849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two weeks of receipt, even if you have no inventory. A BBMI Customer Service Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. Should you have any questions or concerns regarding the attached information, please contact our Customer Support Department at (800) 227-2862.
Quantity in Commerce 1704 units
Distribution US Distribution to: AL, IL, OK, MN, MA and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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