| Date Initiated by Firm |
April 07, 2020 |
| Create Date |
June 01, 2020 |
| Recall Status1 |
Terminated 3 on January 22, 2021 |
| Recall Number |
Z-1935-2020 |
| Recall Event ID |
85549 |
| Product Classification |
Stretcher, wheeled, powered - Product Code INK
|
| Product |
Stryker Power-PRO TL cot-powered ambulance cot
Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults). |
| Code Information |
Serial Numbers: 1909003700051 1909003700052 1909003700055 1909003700056 1909003700057 1909003700058 1909003700059 1909003700060 1909003700061 1909003700062 1909003700065 1909003700066 1909003700067 1909003700068 1909003700069 1909003700070 1909003700072 1909003700073 1909003700074 1909003700075 1909003700076 1909003700077 1909003700078 1909003700079 1909003700080 1909003700081 1909003700082 1909003700083 1909003700084 1909003700085 1909003700086 1909003700087 1909003700088 1909003700090 |
Recalling Firm/
Manufacturer |
Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
|
| For Additional Information Contact |
Victoria Haney
269-552-8209
|
Manufacturer Reason
for Recall |
Ambulance Cots may not meet crash test standard BS EN 1789
|
FDA Determined
Cause 2 |
Component change control |
| Action |
Stryker issued Initial notification to International distribution partners via electronic notification system on 4/7/20. Customers will be notified by written letter distributed via traceable methods. Letter states reason for recall, health risk and action to take:
1. Locate the units listed on the attached business reply form and identify the address where they can be serviced.
2. Return the enclosed business reply form to confirm receipt of this notification by fax or email 269 488 8691 or email productfieldaction@stryker.com the enclosed acknowledgement of this notification.
Power-PRO" TL cot crash test standard
Model: 6550
GTIN: 07613327261660
Month dd, yyyy
Attn: Recall Coordinator/ Fleet Manager
URGENT: URGENT:
MEDICAL DEVICE MEDICAL DEVICE MEDICAL DEVICE MEDICAL DEVICE CORRECTIONCORRECTIONCORRECTION CORRECTION CORRECTIONCORRECTION
Model numbers
Product description
Serial number(s)
6550-000-000
Power-PRO" TL cot manufactured between
Sept 9, 2019 and Nov 7, 2019
See Attachment
Pg. 2
3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Power-PRO " TL cot.
4. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form.
5. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form.
If you have any questions or concerns, please contact Customer Service +1 800 327 0770. Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST). |
| Quantity in Commerce |
34 units |
| Distribution |
Foreign: UK |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
