Reported Sep 5, 2012 · Terminated
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1…
Unimed Surgical Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Unimed Surgical Products, Inc. · 10401 Belcher Rd South · Largo, FL · 33777-1415
Is this the product you have?
- Product is labeled in part"***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***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 # ES0016 -- Lot #: 030608-01 and 121808-19
- Product UsageIntended for cutting and coagulation of soft tissue
- Lot codes and dates
Lot #s: 030608-01121808-19
- Amount recalled
- 1440 ea
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
- IL
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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