Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
What this means for you
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 FDA classified this as a Class II recall, and the source text does not explicitly state that no injuries or illnesses have been reported, nor does it describe the hazard as purely theoretical.
Plain-English summary
Progressive Medical, Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes, specifically the Laparoscopic Electrode PTFE Coated L Hook 33cm Length (Product number P0020). The recall involves 173 boxes containing 6 units each, with lot numbers 071212-05 and 081712-06. The products were distributed nationwide to specific states 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.
The reason for the recall is that the product coatings require 510K approval. The FDA has classified this as a Class II recall. No specific injuries or illnesses are reported in the source text.
Healthcare facilities and consumers should stop using these specific electrodes and contact Progressive Medical, Inc. for further instructions or a refund.
The recalled product
- 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
- 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 numbers 071212-05 and 081712-06
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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