Applied Medical Recalls Stealth Spring Clips for Vascular Occlusion Failure
Applied Medical Resources Corp is recalling 750 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a surgical device failing to occlude vessels, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Applied Medical Resources Corp is recalling 750 units of the Stealth Spring Clip 6mm latis (1/4 Force), a non-sterile surgical device. The specific lot number is 1360163, with a manufacture date of July 3, 2019, and an expiration date of July 3, 2024.
The recall was initiated because the cardiovascular clips may fail to provide sufficient occlusion of the vessel. This device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
The affected units were distributed worldwide, including nationwide in the United States and in 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 clips and contact the manufacturer for further instructions.
The recalled product
- Product
- STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 750
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 # 1360163
- Manufacture Date July 3
- 2019
- Expiration Date July 3
- 2024
Distribution
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.
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