Date Initiated by Firm |
November 11, 2014 |
Date Posted |
December 12, 2014 |
Recall Status1 |
Terminated 3 on February 04, 2016 |
Recall Number |
Z-0527-2015 |
Recall Event ID |
69743 |
510(K)Number |
K880863 K934320
|
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
Product |
Alcon 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 Contact |
Alcon 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 |
Action |
On 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 Commerce |
2321 |
Distribution |
Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = GEI and Original Applicant = MENTOR O & O, INC. 510(K)s with Product Code = GEI and Original Applicant = NEW ENGLAND SURGICAL INSTRUMENT CORP.
|