Device 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.
Z-1236-2015
Product summary
- Firm
- Zipline Medical
- Event
- Event 70466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3109 total, all model numbers
- Official record key
device-enforcement:Z-1236-2015
Official wording
Reason: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Code information: Lot 1002539, Exp 2015-06; 1002719, Exp.2015-08; 1002887, Exp 2015-10; 1003054, Exp 2015-12
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
Derived failure modes
-
Unknown
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.