—#153696

Product

HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K963088
Affected lot / code info: Affected Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284

Why it was recalled

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were Sterile.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

ConMed sent an URGENT: MEDICAL DEVICE RECALL Notices (dated 2/28/2017)to all affected US customers by USPS First Class Mail. International letters are in the process of translation and are scheduled to be sent by March 15, 2017. Customers were instructed to review their inventory for any of the affected product and were asked to complete the business reply form and return it to ConMed Corporation, 525 French Road, Utica, New York 13502. Customers with questions or requests should contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email hyfr2000@conmed.com. For questions regarding this recall call 315-624-3533.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Timeline

Recall initiated: 2017-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153696. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.