| ||Class 2 Device Recall Power Load |
||December 19, 2012
||Terminated on August 30, 2013
|Recall Event ID
Stretcher, wheeled -
||The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
||Item 6390000000 Serial Numbers:
Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
|For Additional Information Contact
|Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.
||All in process and Load Switch Slides within Stryker control were quarantined on 09/27/2012. Direct accounts were telephoned beginning 10/26/2012 with "Urgent Medical Device Correction" notices sent beginning on 11/30/2012. The notices explained the reason for the recall, hazards involved, and recommended actions. Stryker field service was to contact consignees to schedule replacement of the affected load switch slide. Consignees were asked to forward a copy of his notice to the new users and advise Stryker of their new location. Questions or concerns should be directed to (269) 389-6927 or (269) 389-6954.
|Quantity in Commerce
||USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = FPO and Original Applicant = STRYKER MEDICAL