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Espiner Medical Ltd recalls Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage
Recalled November 21, 2018 · FDA recall Z-0444-2019 · Espiner Medical
Hazard
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml · FDA Class II
Units
230 units
Sold at
US Nationwide in the states of CA, IL, MT, NC, NJ,
Description
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
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 the bag, so that it can be pulled closed and removed from the body cavity.
Manufacturer(s)
Espiner Medical Ltd
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →