Recall Z-2024-2014 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
Aesculap, Inc.
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
| Date | Jul 9, 2014 (initiated Jun 13, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| 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. |
| Quantity | 11 |
| Distribution | Distributed in the states of IL, NY, GA, and RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990090 | DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE Aesculap, Inc., Mar 22, 1999 |