—#171741

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.

FDA product code: HIF — Insufflator, Laparoscopic
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K063367
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-03-07
Terminated: 2024-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171741. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.