FDA-Device2014-07-16Class II
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
Aesculap, Inc.
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.
Sold states
Distributed in the states of IL, NY, GA, and RI.
Affected count
11
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2024-2014Don't want to check this manually?
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