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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81480

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 22, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
WOM World of Medicine AG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0508-2019
Recall number
Z-0508-2019
Initiated
October 22, 2018
Classification
Class II
Status
Terminated
Recalling firm
WOM World of Medicine AG
Quantity
124,180 tube sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It is possible that the packaging of the product can be damaged by the prongs on the tube set.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lots from 4011926 to 4013513 (ALL)

Distribution pattern

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