🔍 RecallPedia

OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Class I - Dangerous
🏥 Medical Devices Recalled: October 5, 2016 Oscor Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot #'s: C1-09374 Exp. November 5, 2017, C1-10319 Exp. May 11, 2018, C1-11202 Exp. August 24, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11671 Exp. September 30, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11672 Exp. September 30, 2018, and C1-09374 Exp. November 5, 2017
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 C70¿ S79CM D84CM Catalog # AB081045 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: C1-09374 Exp. November 5, 2017, C1-10319 Exp. May 11, 2018, C1-11202 Exp. August 24, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11671 Exp. September 30, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11672 Exp. September 30, 2018, and C1-09374 Exp. November 5, 2017

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.gov

FDA Recall Number: Z-0795-2017

Related Recalls

TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

Oscor

Class I - Dangerous

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.

Sep 26, 2018 Other Medical Devices Nationwide View Details →