Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Stryker Model Number: 0904-410-000; Lot# 61406001
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Instruments Div. of Stryker Corporation
- Reason for Recall:
- Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.
Product Codes/Lot Numbers:
Stryker Model Number: 0904-410-000; Lot# 61406001
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2102-2015
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