Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 5, 2018
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 peri
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Wom World of Medicine Ag recalled PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set i… - a moderate-severity action.
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set i… was recalled by Wom World of Medicine Ag in December 5, 2018. Reason: It is possible that the packaging of the product can be damaged by the prongs on the tube set.. Check the official notice for the remedy. Verify recall #Z-0508-2019 with the FDA Devices before acting.
The recall
Wom World of Medicine Ag issued this moderate-severity FDA Devices recall-It is possible that the packaging of the product can be damaged by the prongs on the tube set..
- Moderate
- severity level
- Class II
- classification
- December 5, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0508-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0508-2019) was formally reported on December 5, 2018, with the manufacturer initiating the action on October 22, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Wom World of Medicine Ag is listed as the recalling firm, operating out of Berlin, N/A. Federal records list the affected scope as 124,180 tube sets.
The documented reason for this recall is: It is possible that the packaging of the product can be damaged by the prongs on the tube set. Distribution data in the federal record shows the product reached: Worldwide Distribution - US in the state of California and country of Netherlands. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
124,180 tube sets
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0508-2019 |
| Date reported | December 5, 2018 |
| Date initiated | October 22, 2018 |
| Recalling firm | Wom World of Medicine Ag |
| Firm location | Berlin, N/A |
| Affected scope | 124,180 tube sets |
| Distribution | Worldwide Distribution - US in the state of California and country of Netherlands |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0508-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Wom World of Medicine Ag. Units affected: 124,180 tube sets.
Why was this product recalled? ▼
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 5, 2018. Severity: Moderate. Recall number: Z-0508-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US in the state of California and country of Netherlands.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0508-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 5, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.