FDAJune 20, 2018device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
What to do
FDA enforcement status: Terminated
Brands named
espiner medicalespiner
UPCs
5060358120367
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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