AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GUDID: 25051684026298; Lot Number DP-11759
- 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:
- Potential for open seal on sterile product
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Product Codes/Lot Numbers:
GUDID: 25051684026298; Lot Number DP-11759
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1329-2021
Related Recalls
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
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.
The Reusable Oscor ATAR extension cables could separate from the connector during use.