Stryker Portal Entry Kit Recalled Due to Expired Product Distribution
Stryker Corporation recalled 19 Portal Entry Kits distributed to surgical facilities in multiple U.S. states due to expired product. The kits aid surgeons in establishing arthroscopic portals.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving expired medical device distributed to healthcare facilities. Expired surgical equipment is a risk-of-harm product due to potential loss of sterility and device function integrity. No illnesses or injuries have been reported.
Plain-English summary
Stryker Corporation issued a recall of 19 Portal Entry Kits (REF: CAT00241, Lot #007047) that were distributed in expired condition. The kits contain a skin marker, disposable ruler, two FlexSticks, a 30-milliliter syringe, and two 17-gauge needles, and are used to help surgeons establish arthroscopic portals and access surgical joints.
The affected kits were distributed to surgical facilities in New Hampshire, Texas, New York, New Jersey, Ohio, and Minnesota. No injuries or adverse events have been reported related to this recall.
Healthcare facilities that received these kits should verify the expiration date and refrain from using expired product. Those with affected lots should contact Stryker Corporation for guidance on replacement or proper disposal.
The recalled product
- Product
- 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.
- Manufacturer
- Stryker Corporation
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 007047/UDI: 07613252632863
Distribution
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