Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling Epix latis GRASPER devices 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 involves a risk-of-harm product (tissue damage) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Applied Medical Resources Corp is recalling 32,760 units of Epix latis GRASPER, 5 mm x 35 cm, REF C4130. The recall involves specific batches with expiration dates ranging from July 28, 2022, to December 17, 2022. The devices were distributed across all 50 US states, Puerto Rico, and numerous 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. This defect has the potential for tissue to catch on the rivet during use, which could lead to tissue damage. The agency classified this as a Class II recall.
Healthcare providers and facilities should stop using the affected devices and contact Applied Medical Resources Corp for instructions on how to return or dispose of the products. Patients who have had these devices used on them should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
- Manufacturer
- Applied Medical Resources Corp
- Hazard
- Affected units
- 32,760
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 (15)
- Batch: 1364578/Expiration Date: July 28
- 2022
- Batch: 1366453/Expiration Date: August 13
- Batch: 1371249/Expiration Date: October 3
- Batch: 1373050/Expiration Date: October 23
- Batch: 1373248/Expiration Date: November 4
- Batch: 1373249/Expiration Date: November 11
- Batch: 1373255/Expiration Date: November 18
- Batch: 1373260/Expiration Date: November 19
- Batch
- 1373261/Expiration Date: November 24
- Batch: 1373262/Expiration Date: December 2
- Batch: 1373263/Expiration Date: December 5
- Batch: 1377363/Expiration Date: December 11
- Batch: 1377364/Expiration Date: December 17
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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