This voluntary medical device correction is related to recall
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These…
Why was This voluntary medical device correction is related to recalled?
This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.
- Product
- This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These…
- Recalling firm
- Alcon Research, LTD.
- Quantity
- 93,319 (30, 413 distributed domestically & 62,906 internationally)
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
- Recall date
- October 3, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)