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U.S. Department of Health and Human Services

Class 2 Device Recall PNEUMOCLEAR

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  Class 2 Device Recall PNEUMOCLEAR see related information
Date Initiated by Firm October 22, 2018
Create Date November 27, 2018
Recall Status1 Terminated 3 on May 06, 2021
Recall Number Z-0508-2019
Recall Event ID 81480
510(K)Number K170784  
Product Classification Insufflator, laparoscopic - Product Code HIF
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.
Code Information Lots from 4011926 to 4013513 (ALL)
Recalling Firm/
WOM World of Medicine AG
Salzufer 8
Berlin Germany
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HIF and Original Applicant = W.O.M World Of Medicine GmbH