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Zipline Medical recalls Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and aft
Recalled March 11, 2015 · FDA recall Z-1236-2015 · Zipline Medical
Hazard
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. · FDA Class II
Units
3109 total, all model numbers
Sold at
Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
Description
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Product
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.
Manufacturer(s)
Zipline Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →