Z-1235-2015 Class II Terminated
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