Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm)
FDA device recall Z-1839-2015 · posted 2015-06-25 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
- Action taken
- Ethicon initiated this voluntary recall by sending an Urgent: Medical Device Recall (Removal) Letter/Business Reply Form (BRF) dated May 8, 2015 to their affected customers via UPS. Stericycle will be handling returns. The letters identified the affected device and the reason for the recall. Customers were asked to examine their inventory immediately to determine if they had affected devices on hand. If so, they are to remove the affected product and communicate the issue to any necessary personnel. Customers with questions were advised to contact their local sales representative or call the Customer Support Center at 1-877-384-4266. For questions regarding this recall call 908-218-0707.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GAL
- Quantity affected
- 1,922 units
- Distribution
- Worldwide Distribution -- US (nationwide) and Canada.
- Date initiated
- 2015-05-08
- Date posted
- 2015-06-25
- Date terminated
- 2017-06-06
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK (K946173) | ETHICON, Inc. | 1995-01-09 |