Clevedon, United Kingdom
Espiner Medical Ltd recalls
1 recall recorded since 2018, most recently on 20 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 June 2018
- Terminated
- 9 December 2019
- Reason
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0444-2019
- 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 i
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.