Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot 1002690, Exp 2015-08
  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:
Zipline Medical
Reason for Recall:
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

Product Codes/Lot Numbers:

Lot 1002690, Exp 2015-08

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1234-2015

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