Z-0748-2017Class II

ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE...

Name: Z-0748-2017 ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE...
Creator: Ellman International, Inc.
Published: 2016-09-07
License: https://open.fda.gov/license/

Ellman International, Inc. / initiated 2016-09-07 / Terminated / root cause: manufacturing process

FDA source

Ellman International, Inc. began a recall of ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory... on 2016-09-07. FDA classified it as Class II and gives the reason as "Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0748-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Posted: 2016-12-13
Terminated: 2018-06-18
Recalling firm: Ellman International, Inc.
Product: ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Cynosure, Inc. dba Ellman distributed Urgent Medical Device Recall Notices dated September 6, 2016, and response forms to their customers via UPS overnight. Cynosure has identified an error in the Expiration Date on the label of the Minor Surgery Bipolar Cable pouch. The Expiration Date on the individual pouches that are provided in the 5 pack boxes do not match the Expiration Date on the box. The Expiration Date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. Actions To Be Taken - Return any cables subject to recall. You will be contacted by a Cynosure Customer Service Representative who will provide you with a RMA number for any cables that are being returned. Complete and return the response form via email to [email protected]. Cynosure will replace affected products at no charge upon receipt of the returned cables. Customers with questions should call 978-256-4200 or 800-886-2966. For questions regarding this recall call 516-267-6502.
Quantity in commerce: 370 boxes (US - 159 boxes, OUS - 211 boxes)
Distribution: Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.
Product codes and lots: Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0748-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0748-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-13

Product code GEI

K123366Class IISurgitron 4.0 Dual RF S5-IecEllman International, Inc. / cleared 2013-07-12

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)