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 risk of insufficient vessel occlusion 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 and involves a structural defect in a surgical device that could lead to significant injury or property damage, meeting the criteria for a Severe rating.
Plain-English summary
Applied Medical Resources Corp is recalling 2,240 units of the Stealth Spring Clip 6mm latis (1/4 Force), reference number A1602. The recall affects lot number 1360356, which was manufactured on July 5, 2019, and has 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 products were distributed worldwide, including nationwide 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 consumers 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). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- Manufacturer
- Applied Medical Resources Corp
- 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 # 1360356
- Manufacture Date July 5
- 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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