Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Brand
Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
Lot Codes / Batch Numbers
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
Products Sold
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
Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa is recalling Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110 due to 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 an. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Recall60819877@appliedmedical.com 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 atjrios@appliedmedical.com. For regulatory questions, please contact Lauren Contursi at (949) 713-8767 or by email at lcontursi@appliedmedical.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, PR
Page updated: Jan 10, 2026