Home / Recalls / Applied Medical Resources Corp / Z-1388-2024

Z-1388-2024 Class II Ongoing

Recalled by Applied Medical Resources Corp — Rancho Santa Margarita, CA

FDA device recall Z-1388-2024 was initiated by Applied Medical Resources Corp on January 30, 2024 and is designated Class II. Reason for recall: Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. The recall status is ongoing. Affected quantity: N/A.

Recall Details

Product Type
Devices
Report Date
April 3, 2024
Initiation Date
January 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Epix Universal Clip Applier, REF: CA500, STERILEEO

Reason for Recall

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Venezuela.

Code Information

UDI: (01)00607915125318/Lot Codes: 1475580 1475581 1477351 1477352 1477353 1477354 1477355 1477356 1477357 1477358 1477359 1478016 1478017 1478018 1478019 1478089 1478155 1478925 1478926 1478927 1479771 1479772 1479773 1479774 1479969 1479971 1482641 1482644 1482645 1482646 1482647 1482648 1482649 1482954 1484000 1484004 1484005 1484021 1484022 1484023 1484024 1484025 1484026 1486035 1486036 1486037 1486038 1486039 1487790 1487791 1487792 1488875 1488876 1488877 1488878 1488910 1488967 1488968 1488969 1489421 1489531 1489532 1489874 1489895 1489896 1489897 1489898 1490284 1490315 1490523 1490524 1491058 1491059 1491060 1491910 1491914 1491916 1492220 1493194 1493195 1493196 1493197 1493198 1493420 1493421 1493422 1493423 1493568 1493569 1493590 1493591 1494324 1494470 1494471 1495262 1495263 1495270 1495807 1495808 1495809 1495830 1495831 1495832 1495833 1495834 1495835 1495836 1495837 1495838 1495839 1495840 1495841 1495842 1495843 1495844 1495845

Other recalls by Applied Medical Resources Corp

  • Z-1010-2026 Class II — Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 (December 11, 2025)
  • Z-1389-2024 Class II — Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following (January 30, 2024)
  • Z-2158-2020 Class II — Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, U (March 17, 2020)
  • Z-2161-2020 Class II — Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) (March 17, 2020)
  • Z-2159-2020 Class II — Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UD (March 17, 2020)
  • Z-2160-2020 Class II — DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 (March 17, 2020)
  • Z-2034-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - P (January 31, 2020)
  • Z-2035-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - P (January 31, 2020)
  • Z-2036-2020 Class II — STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - P (January 31, 2020)
  • Z-2037-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607 (January 31, 2020)

FDA data resources