Recall Z-1235-2015— Zipline Medical
Class II · Terminated
Class II FDA medical device recall by Zipline Medical, initiated 2015-02-05, terminated 2015-04-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility..
- Recalling firm
- Zipline Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-05
- Terminated
- 2015-04-10
- Firm location
- Campbell, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.