Z-0327-2017Class II

Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection...

Name: Z-0327-2017 Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection...
Creator: B. Braun Medical, Inc.
Published: 2016-07-11
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2016-07-11 / Terminated / root cause: packaging

FDA source

B. Braun Medical, Inc. began a recall of Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia on 2016-07-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0327-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-11
Posted: 2016-11-01
Terminated: 2017-03-15
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
Product code: LRP Tray, Surgical
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.
Root cause tag: packaging
FDA 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 [email protected] 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0327-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0327-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-01

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)