CONTIPLEX Continuous Peripheral Nerve Block Tray — Class II medical device recall Z-1576-2015
Terminated recall by B. Braun Medical, Inc., reported 2015-05-13, distributed nationwide. There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. Thi
| Recall number | Z-1576-2015 |
|---|---|
| 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 | 2015-03-27 |
| Classified | 2015-05-04 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2017-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 5,000 |
| Reason classes | sterility |
| Lot numbers | 61411483, 61411528, 61412387, 61412398, 61413390, 61413393, 61414411, 61414417, 61414419, 61414464, 61414468, 61414481, 61414485, 61414492, 61414589, 61414591, 61415001, 61415013, 61415022, 61415023, 61415024, 61415028, 61415037, 61415040, 61415041, 61415044, 61415051, 61415053, 61415708, 61415712, 61415921, 61415924, 61416362, 61416382, 61416385, 61416390, 61416395, 61416399, 61417210, 61418020 and 3 more |
Product
CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray
Reason for recall
There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space.
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-1576-2015. 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.