Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrati
FDA device recall Z-1544-2015 · posted 2015-04-29 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Reason for recall
- A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
- Action taken
- US Consignees were notified by an Urgent: Voluntary Medical Device Recall letter on 3/30/15 delivered by traceable courier service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review their inventory, identify affected products, and immediately stop use and remove them from service. Customers are to complete the attached form and return via mail or fax. Upon receipt of the form, Customer Service will provide an RMA number and directions for returning the affected products to the firm. Customers should contact Customer Service at 1-800-241-2210 with any questions regarding the instructions.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- BSP
- Quantity affected
- 90 Tuohy needles (9 cases of 10 each)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-03-30
- Date posted
- 2015-04-29
- Date terminated
- 2015-06-24
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPIDURAL ANESTHESIA NEEDLES (K854816) | Reganes, Inc. | 1985-12-19 |