Applied Medical Resources Recalls Laparoscopic Graspers Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling 21 units of Dr. Thames Lap Chole laparoscopic graspers because a protruding rivet may cause tissue damage during use.
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 is classified as FDA Class II, and the hazard involves a risk of tissue damage during surgical use, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Applied Medical Resources Corp is recalling 21 units of the Dr. Thames - Lap Chole laparoscopic grasper (Ref: K0880). The recall involves specific batches with expiration dates ranging from August 13, 2022, to October 30, 2022.
The recall was initiated because there may be a slightly protruding rivet on the distal end of the device. This defect has the potential for tissue to catch on the rivet during use, which could lead to tissue damage.
The affected units were distributed to various locations in the United States, including Alabama, Arkansas, Arizona, California, and others, as well as to numerous international destinations such as Canada, the United Kingdom, and Germany. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
- Manufacturer
- Applied Medical Resources Corp
- Hazard
- Affected units
- 21
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)
- Batch: 1378830/Expiration Date: September 8
- 2022
- Batch: 1379253/Expiration Date: August 13
- Batch: 1380094/Expiration Date: August 22
- Batch: 1381695/Expiration Date: October 30
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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