Z-1727-2019Class II

Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the...

Name: Z-1727-2019 Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the...
Creator: Stryker Corporation
Published: 2019-03-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-03-07 / Terminated

FDA source

Stryker Corporation began a recall of 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... on 2019-03-07. FDA classified it as Class II and gives the reason as "The heated tube sets were consistently leaking and detaching from the cassette". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1727-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Posted: 2019-06-04
Terminated: 2024-03-08
Recalling firm: Stryker Corp.
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.
Product code: HIF Insufflator, Laparoscopic
Reason for recall: The heated tube sets were consistently leaking and detaching from the cassette.
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1727-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1726-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1727-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1728-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code HIF

K063367Class II45L Core Insufflator, Model F114W.O.M. World of Medicine AG / cleared 2007-05-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)