Recall Z-1350-2019— Stryker Medical Division of Stryker Corporation

Name: FDA recall Z-1350-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-20

Class II · Terminated

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2018-11-20, terminated 2020-07-09. It names one FDA 510(k) clearance: K113598. Product: Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000. Reason: The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken..

Recalling firm: Stryker Medical Division of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-11-20
Terminated: 2020-07-09
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K113598 — POWER-LOAD COT FASTENER SYSTEMStryker Medical·cleared 2011-12-20

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

Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000

Reason for recall

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

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