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U.S. Department of Health and Human Services

Class 2 Device Recall Espiner Tissue Retrieval System

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  Class 2 Device Recall Espiner Tissue Retrieval System see related information
Date Initiated by Firm June 20, 2018
Create Date November 10, 2018
Recall Status1 Terminated 3 on December 09, 2019
Recall Number Z-0444-2019
Recall Event ID 81003
510(K)Number K111845  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
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.
Code Information Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08 
Recalling Firm/
Manufacturer		 Espiner Medical Ltd
Yeo Bank
3, Kenn Road
Clevedon United Kingdom
Manufacturer Reason
for Recall		 Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
FDA Determined
Cause 2		 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 in Commerce 230 units
Distribution US Nationwide in the states of CA, IL, MT, NC, NJ,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = ESPINER MEDICAL LIMITED
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