The Recall Desk
HighFDA (Devices)·Z-0734-2013·Announced 2013-01-30

ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals

ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

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 recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

ConMed Corporation is recalling UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108. The recall involves 313,190 units distributed worldwide, including the United States, Puerto Rico, and 22 other countries. The affected lot codes range from 120628X to 120917X.

The recall was initiated after ConMed received complaints that some devices had broken through the seal of the sterile pouch. The company confirmed that the pouch seals were compromised on the affected products. The compromised seals were discovered prior to use in all reported instances.

ConMed has not received any reports that a compromise in the sterile barrier resulted in illness or injury. Healthcare providers and consumers should stop using these devices and contact ConMed for further instructions.

The recalled product

Product
UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Manufacturer
ConMed Corporation
Category
Medical Device — Electrosurgical Accessories
Hazard
Affected units
313,190

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 (9)

  • Beginning Lot Code 120628X
  • 09 represents the month (September)
  • 17 represents the day of the month
  • and X represents the manufacturing shift code (1
  • 2
  • 3
  • 4
  • 5
  • 6 or 9)].

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 20 recalled by ConMed Corporation 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 20 products in this recall →

Related recalls

Same manufacturer · ConMed Corporation

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Same hazard · sterility compromise

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