GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Summary
The FDA issued a Class II for GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX by Stryker Medical Division of Stryker Corporation. Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The prod.
Details
Source
Device Recall
External ID
Z-2223-2021
Action Date
2021-08-18
Status
Ongoing
Category
device
Product Description
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Lot/Code Info: Serial Numbers: R52495 R53376 R55047 R56034 M14805 M14885 M14886 M14931 M14936 M14938 M14939 M50074 M50425 M50951 M50956 M54387 R63407 R54523 R54610 R54696 R54698 R60775 R32649 R25384 R35631 R35734 R58735 M15330 R58474 UDI: 07613327169355 07613327169386
Quantity Affected: 33 units
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
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-12
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Medical Division of Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Medical Division of Stryker Corporation have FDA actions?
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2223-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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