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U.S. Department of Health and Human Services

Class 3 Device Recall Atkinson Retrobulbar Anesthesia Needles

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 Class 3 Device Recall Atkinson Retrobulbar Anesthesia Needlessee related information
Date Initiated by FirmJuly 11, 2007
Date PostedAugust 25, 2007
Recall Status1 Terminated 3 on August 28, 2007
Recall NumberZ-1197-2007
Recall Event ID 38382
Product Classification Anesthesia Needles - Product Code HMX
ProductAtkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each.
Code Information Catalog number 8065420920, Lot number 700894M.
FEI Number 1610287
Recalling Firm/
Manufacturer		 Alcon Research, Ltd
6201 South Fwy
Fort Worth TX 76134-2001
For Additional Information ContactGarry Heidel
817-568-6193
Manufacturer Reason
for Recall		Mislabeled: boxes actually contained Tri-Fact needles
FDA Determined
Cause 2		Process control
ActionThe recalling firm telephoned the hospital on 7/11/07 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm issued a recall letter via FedEx on 7/11/07. The firm's representative is making arrangements to pick up the recalled product.
Quantity in Commerce2 boxes
DistributionCA.
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.
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