FDAFDA · Food and drugs·Recall number Z-1234-2015
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.
Published March 11, 2015 · Recall initiated: February 5, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zipline Medical
- Distributor
- Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
- Lot
- Lot 1002690, Exp 2015-08
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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