Recall Z-0444-2019— Espiner Medical Ltd

Name: FDA recall Z-0444-2019
Creator: U.S. Food and Drug Administration
Published: 2018-06-20

Class II · Terminated

Class II FDA medical device recall by Espiner Medical Ltd, initiated 2018-06-20, terminated 2019-12-09. It names one FDA 510(k) clearance: K111845. 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: Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml.

Recalling firm: Espiner Medical Ltd
Classification: Class II
Status: Terminated
Initiated: 2018-06-20
Terminated: 2019-12-09
Firm location: Clevedon, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K111845 — THE ESPINER SAC OR E SACEspiner Medical Limited·cleared 2011-09-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.