FDAClass IINovember 21, 2018

Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol recall

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

Why was Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08

Product
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from…
Recalling firm
Espiner Medical Ltd
Quantity
230 units
Distribution
US Nationwide in the states of CA, IL, MT, NC, NJ,
Recall date
November 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls