FDAFDA · Food and drugs·Recall number Z-2024-2014
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
Published July 16, 2014 · Recall initiated: June 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Distributed in the states of IL, NY, GA, and RI.
- Lot
- Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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