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Recall Observatory FDA recall evidence

Device 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

Z-2024-2014

June 13, 2014

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 68607
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-2024-2014

Official wording

Reason: 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.

Code information: Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055

Distribution pattern: Distributed in the states of IL, NY, GA, and RI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.