Affected Pain Control Tray Component — Class II medical device recall Z-0327-2017
Terminated recall by B. Braun Medical, Inc., reported 2016-11-09, distributed in AL, IL, MA, MN, OK, WI. B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which cont
| Recall number | Z-0327-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2016-07-11 |
| Classified | 2016-11-01 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2017-03-15 |
| Distributed | AL, IL, MA, MN, OK, WI |
| Quantity | 1,704 units |
| Lot numbers | 0061413435, 0061418559, 0061422389, 0061425996, 0061434523, 0061438084, 0061438393, 0061438803, 0061440188, 0061446168, 0061450971, 0061452272, 0061459227, 0061464239, 0061465310 |
| Model numbers | 560399, 560511, 560605, 560631, 560632 |
Product
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0327-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.