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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 64931
Product Type Devices
Status Ongoing
Recalling Firm Progressive Medical Inc
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-12
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries Lot number 082712-12 Class II Product coatings require 510K approval. 11 boxes with 25 units each. Z-1364-2013
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 Lot number 082712-10 Class II Product coatings require 510K approval. 4 boxes containing 6 individually packaged pieces each Z-1363-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-15 Class II Product coatings require 510K approval. 18 boxes with 12 units each. Z-1362-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-03 Class II Product coatings require 510K approval. 39 boxes with 12 units each. Z-1361-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-09 Class II Product coatings require 510K approval. 19 boxes with 6 units each. Z-1360-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-07 Class II Product coatings require 510K approval. 20 boxes with 6 units each. Z-1359-2013
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 Lot numbers 071212-07 and 082712-14 Class II Product coatings require 510K approval. 60 boxes with 6 units each. Z-1358-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-05 Class II Product coatings require 510K approval. 16 boxes with 6 units each. Z-1357-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-04 Class II Product coatings require 510K approval. 27 boxes with 12 units each. Z-1356-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 071212-04 Class II Product coatings require 510K approval. 38 boxes with 6 units each. Z-1355-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-02 Class II Product coatings require 510K approval. 20 boxes with 12 units each. Z-1354-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-08 Class II Product coatings require 510K approval. 20 boxes with 6 units each. Z-1353-2013
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 Lot numbers 071212-06 and 082712-13 Class II Product coatings require 510K approval. 59 boxes with 6 units each. Z-1352-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot numbers 071212-01, 082712-01 and 111212-04 Class II Product coatings require 510K approval. 150 boxes with 12 units each. Z-1351-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot numbers 071212-05 and 081712-06 Class II Product coatings require 510K approval. 173 boxes with 6 units each. Z-1350-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 071212-03 Class II Product coatings require 510K approval. 19 boxes with 12 units each. Z-1349-2013
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 071212-02 Class II Product coatings require 510K approval. 28 boxes with 12 units each. Z-1348-2013
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