The Recall Desk
HighFDA (Devices)·Z-1389-2024·Announced 2024-04-03

Epix Universal Clip Applier Recalled for Clip Load Failure Risk

Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load a clip after the trigger is actuated, potentially impacting surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a surgical device presenting a potential mechanical failure. Per the severity rubric, theoretical risks of harm without reported illnesses or injuries score at most 3 (High).

Plain-English summary

Applied Medical Resources Corp is recalling the Epix Universal Clip Applier (Reference CA500) distributed in surgical kits used for laparoscopic procedures. The recall affects 17,990 units distributed worldwide, including all U.S. states and 31 additional countries.

The manufacturer identified that the Universal Clip applier may fail to load a clip after the trigger is actuated. This potential mechanical failure could prevent the device from functioning during surgical procedures.

The affected devices are identified by multiple kit reference numbers and lot numbers. Healthcare facilities and medical professionals using these kits should verify whether they have received affected product lots.

The recalled product

Product
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT,
Manufacturer
Applied Medical Resources Corp
Category
Medical Device — Surgical instrument
Hazard
  • clip-load-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Reference Number/Lot Number/UDI Number: GK1003
  • AME KIT 54562 1493930 (01)20607915144979(17)250911(30)01(10)1493930 GK1003
  • AME KIT 54562 1499051 (01)20607915144979(17)251030(30)01(10)1499051 GK1003
  • AME KIT 54562 1505559 (01)20607915144979(17)251030(30)01(10)1505559 GK1003
  • AME KIT 54562 1509312 (01)20607915144979(17)260116(30)01(10)1509312 GK1003
  • AME KIT 54562 1510944 (01)20607915144979(17)260327(30)01(10)1510944 GK1004
  • K-19459 1492258 (01)20607915145136(17)240908(30)01(10)1492258 GK1011
  • K-19459 1494291 (01)20607915145136(17)240908(30)01(10)1494291 GK1011
  • K-19459 1496830 (01)20607915145136(17)240908(30)01(10)1496830 GK1011
  • K-19459 1501491 (01)20607915145136(17)240908(30)01(10)1501491 GK1011
  • K-19459 1503409 (01)20607915145136(17)241110(30)01(10)1503409 GK1011
  • K-19459 1505119 (01)20607915145136(17)241003(30)01(10)1505119 GK1011
  • K-19459 1506824 (01)20607915145136(17)250804(30)01(10)1506824 GK1011
  • K-19459 1509999 (01)20607915145136(17)250804(30)01(10)1509999 GK1011
  • K-19459 1512086 (01)20607915145136(17)260202(30)01(10)1512086 GK1014
  • KE39830 COLE 1493549 (01)20607915145723(17)251113(30)01(10)1493549 GK1044
  • KE39830 COLE 1495781 (01)20607915145723(17)250411(30)01(10)1495781 GK1044
  • KE39830 COLE 1498030 (01)20607915145723(17)260131(30)01(10)1498030 GK1044
  • KE39830 COLE 1499053 (01)20607915145723(17)260131(30)01(10)1499053 GK1044
  • KE39830 COLE 1499054 (01)20607915145723(17)260131(30)01(10)1499054 GK1044

Distribution

Distributed nationwide across the United States.

Related recalls

Same category