STRYKER recalled 39,148 NICO Myriad Handpieces sold worldwide due to latex in packaging that could trigger allergic reactions. The latex-containing tape secures components within packaging. Healthcare providers and patients should stop using the device immediately and follow the recall instructions from Stryker.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Corporation or your healthcare provider for instructions. Notification method: Letter
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The NICO Myriad Handpiece family is a surgical handpiece line used in various procedures. The devices are marketed for precision tissue work and are distributed to healthcare facilities.
Latex-containing tape secures packaging components. If latex comes into contact with patients, it can trigger allergic reactions in sensitive individuals.
This recall is not described as part of a broader industry pattern in the available data.
The issue presents a potential allergen exposure risk to patients and healthcare workers handling the devices during packaging and setup.
Recall letter from Stryker and FDA recall listing; manufacturer website.
Recall instructions and potential replacements or refunds are determined by the manufacturer and are not specified in the recall notice.
Keep recall notice, model/lot numbers, photos of packaging, dates of purchase, and all correspondence with the manufacturer.
Model numbers/names: NN-8000, NN-8001, NN-8002, NN-8003, NN-8004, NN-8005, NN-8006, NN-8007, NN-8008, NN-8010, NN-8015, NN-8017, NN-8018, NN-8019, NN-8020, NN-8021, NN-8500, NN-8501, NN-8502, NN-8503. Where sold: Worldwide distribution, including US nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain and the Netherlands. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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Due to nonconforming products being inadvertently distributed.
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