Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after

FDA device recall Z-1234-2015 · posted 2015-03-02 · Terminated

Recall details

Recalling firm

Zipline Medical

Reason for recall

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

KGX

Quantity affected

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.

Date initiated

2015-02-05

Date posted

2015-03-02

Date terminated

2015-04-10

Location

Campbell, CA