FDA recall Z-0444-2019

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.

Reason for recall

Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml

Distribution

US Nationwide in the states of CA, IL, MT, NC, NJ,

Key facts

Status

Terminated

Initiation date

2018-06-20

Report date

2018-11-21

Termination date

2019-12-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clevedon, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0444-2019