Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the Laparoscopic Electrode PTFE Coated L Hook 44cm Length (Product number P0020X). The recall involves 20 boxes with 6 units each, identified by Lot number 082712-08.
The recall was initiated because product coatings require 510K approval. The agency has classified this recall as Class II.
The affected products were distributed nationwide, including in Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington, and Wisconsin. Consumers and healthcare facilities should stop using these products and contact Progressive Medical Inc. for further instructions.
The recalled product
- 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…
- Manufacturer
- Progressive Medical Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 082712-08
Distribution
Part of a larger recall action
This product is one of 17 recalled by Progressive Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
Same manufacturer · Progressive Medical Inc
See all →- ModerateProgressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- ModerateProgressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- ModerateProgressive Medical Recalls PTFE Coated Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- ModerateProgressive Medical Recalls PTFE Coated Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
- HighProgressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
FDA (Devices) · 2013-05-29
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