The Recall Desk
SevereFDA (Devices)·Z-2034-2020·Announced 2020-05-27

Applied Medical Stealth Spring Clip Recall for Insufficient Vessel Occlusion

Applied Medical Resources Corp is recalling 2,240 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a medical device with a significant functional defect that could lead to injury or property damage is rated as Severe (4).

Plain-English summary

Applied Medical Resources Corp is recalling 2,240 units of the Stealth Spring Clip 6mm latis (1/2 Force). The affected product is identified by Lot # 1359929, with a manufacture date of June 28, 2019, and an expiration date of June 26, 2024. The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

The recall was initiated because the cardiovascular clips failed to provide sufficient occlusion of the vessel. This defect could compromise the intended function of the device during surgical procedures.

The affected units were distributed worldwide, including nationwide distribution in the United States and in specific countries such as Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexico, and the Netherlands. Healthcare facilities and distributors should stop using the affected product and contact the manufacturer for further instructions.

The recalled product

Product
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Affected units
2,240

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 (5)

  • LOT # 1359929
  • Manufacture Date June 28
  • 2019
  • Expiration Date June 26
  • 2024

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Applied Medical Resources Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →