Applied Medical Resources Recalls Clip Applier Kits Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling Clip Applier Kits because a protruding rivet on the laparoscopic grasper may catch tissue, causing damage.
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: The recall involves a medical device with a potential for tissue damage during use, which fits the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Applied Medical Resources Corp is recalling 12 units of Clip Applier Kits, Reference K2887. The recall involves specific batches identified as 1380797 and 1382197. These medical devices were distributed across numerous US states and territories, as well as to various international locations including Canada, the United Kingdom, and Australia.
The recall was initiated because there may be a slightly protruding rivet on the distal end of the laparoscopic grasper included in the kit. This defect has the potential for tissue to catch on the rivet during use, which could lead to tissue damage. The agency has classified this recall as Class II.
Healthcare providers and facilities that have received these specific Clip Applier Kits should stop using them immediately. Users should contact Applied Medical Resources Corp for instructions on how to return the affected units for replacement or refund.
The recalled product
- Product
- Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
- Manufacturer
- Applied Medical Resources Corp
- Hazard
- Affected units
- 12
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 (2)
- Batch: 1380797
- 1382197
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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