Recall Z-1234-2015 ยท KGX Tape And Bandage, Adhesive
Zipline Medical
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
| Date | Mar 2, 2015 (initiated Feb 5, 2015) |
| Status | Terminated |
| Reason | The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. |
| Root cause | Packaging process control |
| Action | Zipline sent an Urgent Voluntary product Recall letters to customers on February 5, 2015 by e-mail with possible follow up on site by firm representatives. The letter identified the affected product, problem and actions to be taken. Customers are asked to quarantine inventory immediately and examine the affected lots for complete pouch seals. Any product found with an incomplete seal should be destroyed or returned to ZipLine Medical. Please complete the enclosed response form as soon as possible, even if you no longer have stock of the lot numbers subject to this correction. This informati |
| Quantity | 3109 - total - all model numbers |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.