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Terminated

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

FDA Recall Z-2024-2014 · Posted 2014-07-09

Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeGAR
Date Initiated2014-06-13
Date Terminated2014-10-07
Product Quantity11

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.

Firm Action

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.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990090DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTUREAesculap, Inc. · 1999-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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