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CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, C...

FDA Device Recall #Z-1576-2015 — Class II — March 27, 2015

Recall Summary

Recall Number Z-1576-2015
Classification Class II — Moderate risk
Date Initiated March 27, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm B. Braun Medical, Inc.
Location Allentown, PA
Product Type Devices
Quantity 5000

Product Description

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.

Distribution Pattern

Nationwide Distribution.

Lot / Code Information

Product codes: 331706 332128 331756 551474 551572 551727 551749 551769 551771 551773 551858 551889 551922 551942 552011 555098 555170 555215 555217 555325 555422 530132 530155 551273 551845 551970 551992 555212 555876 560123 560473 530035 530068 333194 333192 332211 332282 332079 332097 332086 332292 Batch Numbers: 61415053 61416382 61416362 61415022 61414464 61415024 61416390 61415028 61415921 61415924 61415023 61414468 61415044 61415051 61415037 61411483 61418020 61418077 61416399 61415041 61416385 61414419 61414589 61415712 61412398 61413393 61414485 61414481 61414591 61417210 61412387 61415001 61415013 61418035 61414411 61413390 61416395 61414492 61415040 61414417 61411528 61415708 expiration dates: 7/31116 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 6/30/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 1/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 9/30/16 7/31/16 6/30/16 6/30/16 3/31/17 2/28/17 7/31/16 7/31/16 7/31/16 1/31/18 7/31/16 7/31/16 6/30/16 7/31/16 2/28/17 6/30/16 1/31/17

Other Recalls from B. Braun Medical, Inc.

Recall # Classification Product Date
Z-1021-2025 Class II Design Options COMBINED SPINAL/EPIDURAL TRAY- ... Dec 4, 2024
Z-3144-2024 Class II AET36 ANESTH EXT SET - Anesthesia Extension Set... Aug 8, 2024
Z-2387-2024 Class II Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-U... Jun 17, 2024
Z-2380-2024 Class II Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE... Jun 17, 2024
Z-2391-2024 Class II Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE... Jun 17, 2024

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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