Recall Z-0444-2019 ยท GCJ Laparoscope, General & Plastic Surgery
Espiner Medical Ltd
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.
| Date | Jun 20, 2018 |
| Status | Terminated |
| Reason | Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml |
| Root cause | Error in labeling |
| Action | Espinar Medical notified the distributor to notify accounts to review inventory, product batches should not be used, and should be segregated if deemed necessary by the hospital/healthcare facility. Complete the acknowledgement form. Contact Global Medical Partners LLC via email at cs@globalmedllc.com or by calling 888.384.8490 to obtain an RGA number for the return of the product. |
| Quantity | 230 units |
| Distribution | US Nationwide in the states of CA, IL, MT, NC, NJ, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111845 | THE ESPINER SAC OR E SAC Espiner Medical Limited, Sep 26, 2011 |