Stryker Corporation Recalls Expired Sterile Surgical Cannula Devices
Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.
What this means for you
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 of expired sterile medical devices with potential for sterility compromise. The hazard represents risk-of-harm in a surgical context with no reported illnesses or injuries, fitting the rubric criterion for score 3.
Plain-English summary
Stryker Corporation has recalled a Class II single-use sterile surgical device (catalog number 0406-630-225) used to direct lesions to targeted treatment sites. The device consists of a cannula with an integral stylet that is removed before electrode insertion.
The recall was initiated because expired products were distributed to customers. Sterile medical devices past their expiration date may no longer maintain the sterility assurance required for safe use in surgical procedures.
The recalled devices were distributed nationwide to facilities in Arkansas, California, Colorado, Florida, and Michigan. The affected lot number is 1000388946.
Healthcare facilities and providers who received these devices should contact Stryker Corporation for further instructions regarding use, return, or replacement of the affected products.
The recalled product
- Product
- This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
- Manufacturer
- Stryker Corporation
- Hazard
- expired-product
- sterility-compromise
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)
- GTIN: 07613327118438 Lot Number: 1000388946
Distribution
Distributed nationwide across the United States.
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