Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, a
Summary
The FDA issued a Class II for Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable by Stryker Corporation. Reason: Expired product distributed.
Details
Source
Device Recall
External ID
Z-0287-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
Lot/Code Info: Lot # 007047/UDI: 07613252632863
Quantity Affected: 19 kits
Reason for Recall
Expired product distributed
Distribution
US: NH, TX, NY, NJ, OH, MN OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-13
Company
San Jose, CA
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 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
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 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 Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0287-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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