Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling Epix latis GRASPER instruments because a protruding rivet may catch tissue and cause 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 involves a risk of tissue damage during use, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Applied Medical Resources Corp is recalling 4,320 units of Epix latis GRASPER, 5mm x 45 cm, REF: C4140. The recall involves specific batches with expiration dates ranging from August 25, 2022, to December 10, 2022.
The recall is due to a potential defect where a slightly protruding rivet on the distal end of the laparoscopic grasper may catch tissue during use, leading to tissue damage. The agency classifies this as a Class II recall.
The affected products were distributed across all 50 U.S. states, Puerto Rico, and numerous international locations including Canada, the United Kingdom, and Australia. Healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
- Manufacturer
- Applied Medical Resources Corp
- Hazard
- Affected units
- 4,320
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 (7)
- Batch: 1366454/ Expiration Date: August 25
- 2022
- Batch: 1371261/Expiration Date: October 7
- Batch: 1371262/Expiration Date: October 14
- Batch: 1373051/Expiration Date: October 29
- Batch: 1373256/Expiration Date: December 1
- Batch: 1376369/Expiration Date: December 10
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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