FDA (Devices) recall action 64931

Progressive Medical Inc recalled 17 products on 2013-05-29

The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.

Products: 17
Announced: 2013-05-29
Critical: 0
Units: —

Why these products were recalled

Product coatings require 510K approval.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–17 of 17

ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical Inc is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical is recalling PTFE coated disposable electrosurgical electrodes because product coatings require 510K approval.
Product
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. Electrode
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Electrosurgical Electrodes
Progressive Medical is recalling PTFE coated disposable electrosurgical electrodes because the product coatings require 510K approval.
Product
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 u
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE coated disposable electrosurgical electrodes because the product coatings require 510K approval.
Product
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 Elec
Category
Distribution
23 states
HighFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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 Electr
Category
Distribution
23 states
HighFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.
Product
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 Electros
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes
Progressive Medical is recalling PTFE coated laparoscopic electrosurgical electrodes because the product coatings require 510K approval.
Product
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 Elect
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Electrosurgical Electrodes
Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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 i
Category
Distribution
23 states
HighFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Laparoscopic Electrodes
Progressive Medical is recalling PTFE coated laparoscopic electrodes because the product coatings require 510K approval.
Product
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 El
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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. Electr
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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 use
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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. Electrod
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Electrosurgical Electrodes
Progressive Medical is recalling PTFE coated disposable electrosurgical electrodes because the product coatings require 510K approval.
Product
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 E
Category
Distribution
23 states
HighFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.
Product
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 i
Category
Distribution
23 states
HighFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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 Elect
Category
Distribution
23 states
ModerateFDA (Devices)··2013-05-29
Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes
Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
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 Electr
Category
Distribution
23 states