Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518
- 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:
- Medtronic Navigation, Inc.
- Reason for Recall:
- The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Product Codes/Lot Numbers:
Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0657-2020
Related Recalls
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