Z-0444-2019Class II

Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367)

Name: Z-0444-2019 Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367)
Creator: Espiner Medical Ltd
Published: 2018-06-20
License: https://open.fda.gov/license/

Fannin (UK) Limited / initiated 2018-06-20 / Terminated / root cause: labeling and UDI

FDA source

Espiner Medical Ltd began a recall of Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop... on 2018-06-20. FDA classified it as Class II and gives the reason as "Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0444-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-20
Posted: 2018-11-10
Terminated: 2019-12-09
Recalling firm: Fannin (UK) Limited
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Root cause tag: labeling and UDI
FDA 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 [email protected] 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,
Product codes and lots: Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0444-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0444-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09

Product code GCJ

K111845Class IIThe Espiner Sac or E SacEspiner Medical Limited / cleared 2011-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)