Z-1234-2015Class II

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

Name: Z-1234-2015 Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during...
Creator: Zipline Medical
Published: 2015-02-05
License: https://open.fda.gov/license/

Zipline Medical, Inc. / initiated 2015-02-05 / Terminated / root cause: packaging

FDA source

Zipline Medical began a recall of 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... on 2015-02-05. FDA classified it as Class II and gives the reason as "The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1234-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Posted: 2015-03-02
Terminated: 2015-04-10
Recalling firm: Zipline Medical, Inc.
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.
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Lot 1002690, Exp 2015-08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1234-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1234-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02
Z-1235-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02
Z-1236-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)