Recall Z-1728-2019— Stryker Corporation

Name: FDA recall Z-1728-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-07

Class II · Terminated

Class II FDA medical device recall by Stryker Corporation, initiated 2019-03-07, terminated 2024-03-08. It names one FDA 510(k) clearance: K003792. Product: Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.. Reason: The heated tube sets were consistently leaking and detaching from the cassette..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Terminated: 2024-03-08
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K003792 — STRYKER HEATED INSUFFLATOR TUBE SETStryker Corp.·cleared 2001-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Reason for recall

The heated tube sets were consistently leaking and detaching from the cassette.

Data sourced from openFDA. This site is unofficial and independent of the FDA.