FDAFDA · Food and drugs·Recall number Z-1352-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Published May 29, 2013 · Recall initiated: April 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product coatings require 510K approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Progressive Medical Inc
- Distributor
- Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
- Lot
- Lot numbers 071212-06 and 082712-13
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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