Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.
- 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 Inc. Cardiac Rhythm Disease Management
- Reason for Recall:
- Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Product Codes/Lot Numbers:
Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1876-2013
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