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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 Insufflatsee related information
Date Initiated by FirmMarch 07, 2019
Create DateJune 04, 2019
Recall Status1 Terminated 3 on March 08, 2024
Recall NumberZ-1727-2019
Recall Event ID 82489
510(K)NumberK063367 
Product Classification Insufflator, laparoscopic - Product Code HIF
ProductStryker 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/
Manufacturer		 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
ActionThe 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 Commerce5,089 boxes
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = HIF
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