Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label a
FDA device recall Z-2024-2014 · posted 2014-07-09 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GAR
- Quantity affected
- 11
- Distribution
- Distributed in the states of IL, NY, GA, and RI.
- Date initiated
- 2014-06-13
- Date posted
- 2014-07-09
- Date terminated
- 2014-10-07
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE (K990090) | Aesculap, Inc. | 1999-03-22 |