Recall Z-2289-2012— Unimed Surgical Products, Inc.

Name: FDA recall Z-2289-2012
Creator: U.S. Food and Drug Administration
Published: 2010-06-16

Class II · Terminated

Class II FDA medical device recall by Unimed Surgical Products, Inc., initiated 2010-06-16, terminated 2012-08-30. It names 2 FDA 510(k) clearances: K962935, K944265. Product: Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013 -- Lot # 030309-02 and 030509-05 Product Usage: Intended for cutting and coagulation of soft tissue.. Reason: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility..

Recalling firm: Unimed Surgical Products, Inc.
Classification: Class II
Status: Terminated
Initiated: 2010-06-16
Terminated: 2012-08-30
Firm location: Largo, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODEUnimed Surgical Products, Inc.·cleared 1996-09-03
K944265 — NEEDLE ELCTRODEUnimed Surgical Products, Inc.·cleared 1995-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013 -- Lot # 030309-02 and 030509-05 Product Usage: Intended for cutting and coagulation of soft tissue.

Reason for recall

On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.

Data sourced from openFDA. This site is unofficial and independent of the FDA.