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.
FDA Recall Z-0444-2019 · Posted None
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Recalling FirmEspiner Medical Ltd
Recall StatusTerminated
Product CodeGCJ
Date Initiated2018-06-20
Date Terminated2019-12-09
Product Quantity230 units
Reason for Recall
Label was incorrect. The label states that the
volume of the retrieval bag was 1200ml, but it should state 1000ml
Firm 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 [email protected] or by calling 888.384.8490 to obtain an RGA number for the return of the product.
Root Cause
Error in labeling
Distribution Pattern
US Nationwide in the states of CA, IL, MT, NC, NJ,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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