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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker High Flow Tube Set with RealTime Pressure Sensing (RTP) for Pneumo Sure High Flow Insufflat

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  Class 2 Device Recall Stryker High Flow Tube Set with RealTime Pressure Sensing (RTP) for Pneumo Sure High Flow Insufflat see related information
Date Initiated by Firm March 07, 2019
Create Date June 04, 2019
Recall Status1 Open3, Classified
Recall Number Z-1727-2019
Recall Event ID 82489
510(K)Number K063367  
Product Classification Insufflator, laparoscopic - Product Code HIF
Product Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Code Information UDI - 07613327055641;  Lot numbers: 18G0273, 18H0323, 18H0354, 56004327, 56004391, 56004434, 56004478, 56004526, 56004592, 56004665, 56004667, 56004706, 56004708, 56004784, 56004832, 56005325, 56005376, 56005378, 56005380, 56005411, 56005450, 56005459, 56005538, 56005540, 56005633, 56005635, 56005744, 56005790, 56005899, 56005901, 56005989, 56005997, 56005999, 56006142,  56006154, 56006270, 56006340, 56006434, 56006521, 56006527, 56006556, 56006560, 56006606. 
Recalling Firm/
Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
Manufacturer Reason
for Recall
The heated tube sets were consistently leaking and detaching from the cassette.
FDA Determined
Cause 2
Under Investigation by firm
Action The recalling firm issued letters dated 3/7/2019 via certified mail on 3/7/2019. A second letter dated 3/7/2019 was issued on 4/15/2019 via certified mail to two customers which included an additional lot number for one of the products.
Quantity in Commerce 5,089 boxes
Distribution Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HIF and Original Applicant = W.O.M. WORLD OF MEDICINE AG