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U.S. Department of Health and Human Services

Class 2 Device Recall Dafilon Suture

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 Class 2 Device Recall Dafilon Suturesee related information
Date Initiated by FirmJune 13, 2014
Date PostedJuly 09, 2014
Recall Status1 Terminated 3 on October 07, 2014
Recall NumberZ-2024-2014
Recall Event ID 68607
510(K)NumberK990090 
Product Classification Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
ProductDafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
Code Information Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055 
FEI Number 2916714
Recalling Firm/
Manufacturer		 Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information ContactCustomer Support
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall		Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.
FDA Determined
Cause 2		Labeling design
ActionA correction and removal notification, dated June 13, 2014, was sent to end users, sales reps, and distributors which described the product, problem, and actions to be taken.
Quantity in Commerce11
DistributionDistributed in the states of IL, NY, GA, and RI.
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 = GAR
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