Z-1330-2016Class II

STD GK258, AME Standard Kit 44

Name: Z-1330-2016 STD GK258, AME Standard Kit 44
Creator: Applied Medical Resources Corp
Published: 2015-12-22
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2015-12-22 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in... on 2015-12-22. FDA classified it as Class II and gives the reason as "Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1330-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-22
Posted: 2016-04-05
Terminated: 2016-10-03
Recalling firm: Applied Medical Resources Corp
Product: STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Product code: MCH Clip, Hemostatic
Reason for recall: Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe. The customer notification letter requested that the following actions be taken: - Check inventory for recalled product. - Complete the attached Recall Notification Confirmation Form to acknowledge the recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested. - Return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to (949) 713-8936. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at [email protected].
Distribution: U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain
Product codes and lots: Lot #: 1238155, 1238402, 1238845

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1330-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1329-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05
Z-1330-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05
Z-1331-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05
Z-1332-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

Product code MCH

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)