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.
Enforcement
- Recall Number
- Z-2289-2012
- Event ID
- 61982
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Unimed Surgical Products, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 5, 2012
- Initiation Date
- June 16, 2010
- Classification Date
- August 28, 2012
- Termination Date
- August 30, 2012
- Address
- 10401 Belcher Rd South, N/A, Largo, FL, 33777-1415, United States
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.
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.
Lot # 030309-02 and 030509-05
US Nationwide Distribution - including the state of IL.
3600 each