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.
Recall
- Recall Number
- Z-0444-2019
- Event Number
- 81003
- Firm
- Espiner Medical Ltd Yeo Bank 3, Kenn Road Clevedon United Kingdom
- FEI Number
- 3009231402
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- June 20, 2018
- Terminated
- December 9, 2019
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.
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
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 [email protected] or by calling 888.384.8490 to obtain an RGA number for the return of the product.
US Nationwide in the states of CA, IL, MT, NC, NJ,
230 units