Z-0508-2019Class II

PNEUMOCLEAR Heated High-Flow Tube Set

Name: Z-0508-2019 PNEUMOCLEAR Heated High-Flow Tube Set
Creator: WOM World of Medicine AG
Published: 2018-10-22
License: https://open.fda.gov/license/

Novanta Medical GmbH / initiated 2018-10-22 / Terminated / root cause: packaging

FDA source

WOM World of Medicine AG began a recall of 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... on 2018-10-22. FDA classified it as Class II and gives the reason as "It is possible that the packaging of the product can be damaged by the prongs on the tube set". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0508-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Posted: 2018-11-27
Terminated: 2021-05-06
Recalling firm: Novanta Medical GmbH
Product: 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.
Product code: HIF Insufflator, Laparoscopic
Reason for recall: It is possible that the packaging of the product can be damaged by the prongs on the tube set.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: WOM sent a Recall Notification letter dated October 22, 2018 to the their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to send all in the US recalled products back to: W.O.M. WORLD OF MEDICINE USA, Inc. 4531 36th Street Orlando, FL 32811-6527 WOM contacts for coordinating the shipment of the requested products to Orlando: Customer Service -W.O.M. Orlando Phone: +1 407 472 0372 Customer Service -W.O.M. Orlando Phone: +1 407 472 0371 Please send all recalled products returned to Stryker Venlo/Netherlands back to: W.O.M. WORLD OF MEDICINE GmbH Alte Poststr. 11 96337 Ludwigsstadt - Germany Customer Service: +49 30 39981 524
Quantity in commerce: 124,180 tube sets
Distribution: Worldwide Distribution - US in the state of California and country of Netherlands
Product codes and lots: Lots from 4011926 to 4013513 (ALL)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0508-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0508-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27

Product code HIF

K170784Class IIPneumoclearW.O.M. World of Medicine GmbH / cleared 2017-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)