| Class 2 Device Recall Stryker | |
Date Initiated by Firm | May 12, 2021 |
Create Date | August 06, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2210-2021 |
Recall Event ID |
88199 |
Product Classification |
Bed, ac-powered adjustable hospital - Product Code FNL
|
Product | InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000 |
Code Information |
Serial Numbers: U54274 U71491 UDI:07613327169294 |
Recalling Firm/ Manufacturer |
Stryker Medical Division of Stryker Corporation 3800 E Centre Ave Portage MI 49002-5826
|
For Additional Information Contact | Victoria Haney 269-389-8306 |
Manufacturer Reason for Recall | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the
correct use environment, but home users may not be aware of or fully understand these instructions
intended for healthcare professionals |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Stryker notified users/consumers via written notification Urgent Medical Device Removal letter notified via FedEx on Friday, June 18, 2021. In addition, customers may be contacted by phone or email. International distribution divisions were notified by validated electronic system (Trackwise) on May 13, 2021.
Letter states reason for recall, health risk and action to take:
Customers are instructed to:
1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number).
2. If you are using the product in a home, Stryker recommends that you discontinue use of the product.
3. Complete and sign the enclosed business reply form.
a. Return this signed letter by fax (269) 488-8691or email productfieldaction@stryker.com to Stryker's Regulatory Department.
1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number).
2. If you are using the product in a home, Stryker recommends that you discontinue use of the product.
3. Complete and sign the enclosed business reply form.
a. Return this signed letter by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers Regulatory Department.
4. Upon receipt of the signed business reply form, Stryker will contact you to arrange the removal of your product(s) if applicable.
If you have any questions or concerns, contact us at +1 269 389 8306 or productfieldaction@stryker.com. We apologize for any disruption this may cause. |
Quantity in Commerce | 2 units |
Distribution | Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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