Z-1363-2013 Class II Terminated
FDA device recall Z-1363-2013 was initiated by Progressive Medical Inc on April 12, 2013 and is designated Class II. Reason for recall: Product coatings require 510K approval. The recall status is terminated (terminated May 7, 2014). Affected quantity: 4 boxes containing 6 individually packaged pieces each.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- April 12, 2013
- Termination Date
- May 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 boxes containing 6 individually packaged pieces each
Product Description
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Reason for Recall
Product coatings require 510K approval.
Distribution Pattern
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.
Code Information
Lot number 082712-10