Espiner Tissue Retrieval System Recalled for Incorrect Volume Labeling
Espiner Medical Ltd is recalling 230 units of the Eco-Sac Tissue Retrieval System because the label incorrectly states the volume is 1200 ml instead of 1000 ml.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding volume, which fits the rubric criteria for moderate severity involving low-risk issues or labeling errors.
Plain-English summary
Espiner Medical Ltd is recalling 230 units of the Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm (model EMP160ECO-US-5). The recall is due to a labeling error where the product label states the retrieval bag volume is 1200 ml, but the correct volume is 1000 ml.
The affected products were distributed nationwide in the United States, specifically in the states of California, Illinois, Montana, North Carolina, and New Jersey. The recall includes specific lot numbers with expiration dates ranging from January 2020 to August 2022.
Healthcare providers and consumers should stop using the affected products and contact the recalling firm for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of…
- Manufacturer
- Espiner Medical Ltd
- Hazard
- Affected units
- 230
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 (4)
- Lot Numbers/Exp Date: A2578 2020/01
- A3162 2020/10
- 1603 2022/0l
- 2184 2022/08
Distribution
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