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Terminated

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.

FDA Recall Z-0508-2019 · Posted None

Recalling FirmWOM World of Medicine AG
Recall StatusTerminated
Product CodeHIF
Date Initiated2018-10-22
Date Terminated2021-05-06
Product Quantity124,180 tube sets

Reason for Recall

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

Firm 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

Root Cause

Packaging process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170784PNEUMOCLEARW.O.M. World of Medicine GmbH · 2017-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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