Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Class I - DangerousWhat Should You Do?
- Check if you have this product: 028912A Exp Date 2017-10-16; 030725A Exp Date 2018-01-08; 031994A Exp Date 2018-03-02; 033625A Exp Date 2018-02-20
- 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:
- Resource Optimization & Innovation Llc
- Reason for Recall:
- Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Product Codes/Lot Numbers:
028912A Exp Date 2017-10-16; 030725A Exp Date 2018-01-08; 031994A Exp Date 2018-03-02; 033625A Exp Date 2018-02-20
Distribution:
Distributed in: US, LA, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1655-2017
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