Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2014-06-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2024-2014
Date of alert
2014-06-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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