OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #'s: OR-04634 Exp. March 10, 2018 and C1-12597 Exp. June 18, 2019
- 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:
- Oscor, Inc.
- Reason for Recall:
- Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Product Codes/Lot Numbers:
Lot #'s: OR-04634 Exp. March 10, 2018 and C1-12597 Exp. June 18, 2019
Distribution:
Distributed in: US, CA, NJ, MD, TX, FL, NC, MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0792-2017
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