Date Initiated by Firm | June 13, 2014 |
Date Posted | July 09, 2014 |
Recall Status1 |
Terminated 3 on October 07, 2014 |
Recall Number | Z-2024-2014 |
Recall Event ID |
68607 |
510(K)Number | K990090 |
Product Classification |
Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
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Product | Dafilon 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 |
Recalling Firm/ Manufacturer |
Aesculap, Inc. 3773 Corporate Pkwy Center Valley PA 18034-8217
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For Additional Information Contact | Customer 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 |
Action | A 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 Commerce | 11 |
Distribution | Distributed in the states of IL, NY, GA, and RI. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = GAR
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