Z-2158-2020Class II

Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

Name: Z-2158-2020 Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Creator: Applied Medical Resources Corp
Published: 2020-03-17
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2020-03-17 / Terminated

FDA source

Applied Medical Resources Corp began a recall of Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147 on 2020-03-17. FDA classified it as Class II and gives the reason as "There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2158-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-17
Posted: 2020-05-28
Terminated: 2022-02-17
Recalling firm: Applied Medical Resources Corp
Product: Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Product code: NWV Laparoscopic Accessories, Gynecologic
Reason for recall: There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
FDA root cause: Under Investigation by firm
Action: Each domestic consignee was notified by Urgent: Medical Device Recall letter, dated March 16, 2020 sent to distributors 3/19/2020 via email and domestic consignees on March 19, 2020 via UPS. It notified customers of recall of specific lots due to the potential for tissue to catch on a slightly protruding riven on the distal end of the device, which may lead to tissue damage. It instructed customers to complete the following actions: 1) Check inventory for recalled product. 2) Complete the attached Customer Recall Notification Confirmation Form (Page 3) to acknowledge the Recall. Please then indicate if your facility is returning or has already used devices from this lot. Please note that you must return the form even if you have no devices in inventory. 3) If a distributor, please notify any facilities to which they distributed the affected product. Please also complete the Distributor Recall Notification Confirmation Form (Page 4). 4) Return the Customer Recall Notification Confirmation Form to Applied Medical by email at [email protected] or fax to (949) 688-2125. 5) Return affected product and a copy of the Customer Recall Notification Confirmation Form to Applied Medical.Product Return Instructions are on Page 5. NOTE: If a distributor, please notify any facilities to which they distributed the affected product. Also,please contact your local regulatory agency. It listed the following contact information for additional questions and/or MDR reporting: For product return questions, please contact Jaclene Rios-Simpson, RGA Dept. at (949) 713-8688 or by email [email protected]. For regulatory questions, please contact Lauren Contursi at (949) 713-8767 or by email at [email protected]. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 32,760 units
Distribution: US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
Product codes and lots: Batch: 1364578/Expiration Date: July 28, 2022; Batch: 1366453/Expiration Date: August 13, 2022; Batch: 1371249/Expiration Date: October 3, 2022; Batch: 1373050/Expiration Date: October 23, 2022; Batch: 1373248/Expiration Date: November 4, 2022; Batch: 1373249/Expiration Date: November 11, 2022; Batch: 1373255/Expiration Date: November 18, 2022; Batch: 1373260/Expiration Date: November 19, 2022; Batch; 1373261/Expiration Date: November 24, 2022; Batch: 1373262/Expiration Date: December 2, 2022; Batch: 1373263/Expiration Date: December 5, 2022; Batch: 1377363/Expiration Date: December 11, 2022; Batch: 1377364/Expiration Date: December 17, 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2158-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2158-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2159-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2160-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2161-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28

Product code NWV

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)