FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia
- Recall number
- Z-0327-2017
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia
- Status
- Terminated
- Initiated
- 2016-07-11
- Posted
- 2016-11-01
- Terminated
- 2017-03-15
- Reason
- 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.
- Root cause
- 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
- 1704 units
- Distribution
- US Distribution to: AL, IL, OK, MN, MA and WI.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRP
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28