CLASS II Device recall · Reported 5 Dec 2018 · FDA Enforcement Report
Pneumoclear Heated High-Flow Tube Set recalled
WOM World of Medicine AG is recalling Pneumoclear Heated High-Flow Tube Set, distributed in California. The recall was initiated on 22 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0508-2019
- FDA event ID
- 81480
- Recalling firm
- WOM World of Medicine AG, Berlin, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2018
- FDA classified
- 27 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 22 Oct 2018 | Recall initiated by company | |
| 27 Nov 2018 | Classified by FDA | +36 days |
| 5 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US in the state of California and country of Netherlands
Questions about this recall
Is Pneumoclear Heated High-Flow Tube Set recalled?
Yes. WOM World of Medicine AG recalled Pneumoclear Heated High-Flow Tube Set on 22 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0508-2019.
Why was it recalled?
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
Which lots are affected?
Lots from 4011926 to 4013513 (ALL)
Where was it sold?
Worldwide Distribution - US in the state of California and country of Netherlands
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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