PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a sing...

FDA Device Recall #Z-0508-2019 — Class II — October 22, 2018

Recall Summary

Recall Number Z-0508-2019
Classification Class II — Moderate risk
Date Initiated October 22, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm WOM World of Medicine AG
Location Berlin, N/A
Product Type Devices
Quantity 124,180 tube sets

Product Description

PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.

Reason for Recall

It is possible that the packaging of the product can be damaged by the prongs on the tube set.

Distribution Pattern

Worldwide Distribution - US in the state of California and country of Netherlands

Lot / Code Information

Lots from 4011926 to 4013513 (ALL)

Other Recalls from WOM World of Medicine AG

Recall # Classification Product Date
Z-2243-2024 Class II WOM Tube Set for lrrlgatlon, single-use- Intend... May 24, 2024
Z-2629-2023 Class II Aquilex Fluid Control System-Intended to provid... Jul 17, 2023
Z-2561-2021 Class II Covidien HysteroLux Fluid Management System Con... Jun 18, 2021
Z-2767-2019 Class II Aquilex Fluid Control System component: Bag def... Aug 14, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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.