Z-1235-2015 Class II Terminated
FDA device recall Z-1235-2015 was initiated by Zipline Medical on February 5, 2015 and is designated Class II. Reason for recall: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. The recall status is terminated (terminated April 10, 2015). Affected quantity: 3109 devices, total all model numbers.
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 devices, total all model numbers
Product Description
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.
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 1002750, Exp 2016-09