Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Mo
Summary
The FDA issued a Class II for Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an by Stryker Medical Division of Stryker Corporation. Reason: Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head.
Details
Source
Device Recall
External ID
Z-1256-2023
Action Date
2023-03-22
Status
Ongoing
Category
device
Product Description
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Lot/Code Info: GTIN: 07613327559118 Serial Numbers: 2208002066, 2208002071, 2209001508, 2208001664
Quantity Affected: 4 units
Reason for Recall
Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.
Distribution
US Nationwide distribution in the states of NY, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
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 134 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-1256-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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