FDA-Device2015-03-11Class II
Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Zipline Medical
Hazard
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Sold states
Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
Affected count
3109 total, all model numbers
Manufactured in
747 Camden Ave Ste A, N/A, Campbell, CA, United States
Products
Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1236-2015Don't want to check this manually?
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