FDA Recall Terminated

Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher

Recall: Z-1185-2016 · Initiated February 5, 2016

Recall

Recall Number
Z-1185-2016
Event Number
73403
Firm
Stryker Medical Division of Stryker Corporation
FEI Number
1831750
Product Code
FPO
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
February 5, 2016
Terminated
September 6, 2016
Address
3800 E Centre Ave, Portage, MI, 49002-5826

Description

Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher

Reason

The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we

Action

On 2/5/2016, URGENT MEDICAL DEVICE NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m.-5 p.m. (ET).

Distribution

Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.

Quantity

36