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U.S. Department of Health and Human Services

Class 2 Device Recall Bipolar Forceps

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 Class 2 Device Recall Bipolar Forcepssee related information
Date Initiated by FirmNovember 11, 2014
Date PostedDecember 12, 2014
Recall Status1 Terminated 3 on February 04, 2016
Recall NumberZ-0527-2015
Recall Event ID 69743
510(K)NumberK880863 K934320 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductAlcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
Code Information Lot numbers 061814-95 and 080614-91
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information ContactAlcon Customer Service
800-862-5266
Manufacturer Reason
for Recall		The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
FDA Determined
Cause 2		Process control
ActionOn November 11, 2014, the firm sent letters to their customers notifiying them of the medical device recall. The recalling firm asked their customers to stop using the recalled product, remove it from inventory, return the affected product, and complete a response form.
Quantity in Commerce2321
DistributionWorldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
510(K)s with Product Code = GEI
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