Home / Recalls / Zipline Medical / Z-1236-2015

Z-1236-2015 Class II Terminated

Recalled by Zipline Medical — Campbell, CA

Recall Details

Product Type
Devices
Report Date
March 11, 2015
Initiation Date
February 5, 2015
Termination Date
April 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3109 total, all model numbers

Product Description

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.

Reason for Recall

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.

Code Information

Lot 1002539, Exp 2015-06; 1002719, Exp.2015-08; 1002887, Exp 2015-10; 1003054, Exp 2015-12

Other recalls by Zipline Medical

  • Z-1234-2015 Class II — Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number (February 5, 2015)
  • Z-1235-2015 Class II — Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number P (February 5, 2015)