FDA-Device2018-11-21Class II
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.
Espiner Medical Ltd
Hazard
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Sold states
US Nationwide in the states of CA, IL, MT, NC, NJ,
Affected count
230 units
Manufactured in
Yeo Bank, 3, Kenn Road, Clevedon, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0444-2019Don't want to check this manually?
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