Stryker PenAdapt Electrosurgical Accessory Recalled for Sterile Barrier Breach
Stryker is recalling 35,310 PenAdapt electrosurgical accessories due to packaging cuts that may breach the sterile barrier and the presence of aluminum shavings.
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: The recall involves a risk-of-harm product (sterile barrier breach and foreign particles in a surgical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 35,310 unexpired units of the Stryker PenAdapt, an accessory used with electrosurgical units (ESU) to remove smoke, particles, and fluids during surgical procedures. The recall was initiated after packaging verification testing revealed cuts in the packaging that could potentially cause a breach in the sterile barrier.
Additional testing identified microscopic aluminum metal shavings and foreign particles, estimated to be between 0.01 inches x 0.015 inches and 0.03 inches x 0.04 inches, which were introduced during the manufacturing process and sterilized within the packaging. The affected product is identified by Part Number 0702-045-027.
The recalled devices were distributed nationwide in the United States, including DC and all 50 states, as well as in Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong. Healthcare facilities and distributors should stop using the affected units and contact Stryker for further instructions.
The recalled product
- Product
- Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizin
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 35,310
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)
- Part Number 0702-045-027
Distribution
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