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
- Company
- Aesculap Inc
- Recall Initiated
- June 13, 2014
- Posted
- July 9, 2014
- Terminated
- October 7, 2014
- Recall Number
- Z-2024-2014
- Quantity
- 11
- Firm Location
- Center Valley, PA
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.
Distribution
Distributed in the states of IL, NY, GA, and RI.
Lot / Code Info
Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055
Root Cause
Labeling design
Action Taken
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.
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