Z-1358-2013 Class II Terminated
FDA device recall Z-1358-2013 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: 60 boxes with 6 units 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
- 60 boxes with 6 units each.
Product Description
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product number P0100X 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 numbers 071212-07 and 082712-14