Device product
Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; 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-1235-2015
Product summary
- Firm
- Zipline Medical
- Event
- Event 70466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3109 devices, total all model numbers
- Official record key
device-enforcement:Z-1235-2015
Official wording
Reason: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Code information: Lot 1002750, Exp 2016-09
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.