FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1234-2015
- Recalling firm
- Zipline Medical
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-02-05
- Posted
- 2015-03-02
- Terminated
- 2015-04-10
- 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 information is required to reconcile the inventory. Please contact Customer Service at 1-888-326-8999 to coordinate any product returns, replacement stock, or credit notes.
- 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.
- Lot, serial or model codes
- Lot 1002690, Exp 2015-08
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGX
- Firm FEI
- 3009673389
- Firm city
- Campbell
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28