ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: W3101005
- 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:
- Greatbatch Medical
- Reason for Recall:
- Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Product Codes/Lot Numbers:
Lot Number: W3101005
Distribution:
Distributed in: NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2781-2017
Related Recalls
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.
On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA.