Reported Nov 21, 2018 · Terminated

Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage:…

Espiner Medical Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Espiner Medical Ltd · Yeo Bank · Clevedon · N/A

Is this the product you have?

  • Espiner Tissue Retrieval
  • System-Eco-Sac Trocar 12mm Vol1200
  • ml EMP160ECO-US-5 (GTIN5060358120367)
  • Product UsageTissue 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
Lot codes and dates
  • Lot Numbers/Exp Date
    • A2578 2020/01
    • A3162 2020/10
    • 1603 2022/0l
    • 2184 2022/08
Amount recalled
230 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 9, 2019 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.