Device Recall Integra Long Epidural Steroid Injection Needle (Tuohy Needle) 의 리콜

Recall

71147

Class 2

Z-2056-2015

2015-05-01

2015-07-09

Terminated

United States

2015-12-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136261

Integra lifesciences corp. d.B.A. integra pain management announces voluntary recall of tuohy needles (20 gauge, 5 inch) due to incorrect packaging (labeled as 18 gauge, 3. 5 inch).

Integra sent an Urgent Voluntary Medical Device Recall letter dated May 1, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Integra is asking customers to do the following: 1. Review your inventory and determine if you have Tuohy Needle, 20 Gauge X 5 inches (Cat. No. PITRW2050) with an affected Lot Number that is listed on page 2. If so, stop using them immediately and remove them from service. 2. Complete the attached form. If you do not have affected product, check the box:  I do not have any product(s) with a Lot Number from the list below. 3. If you do have affected product, check the box:  I do have product(s) with a Lot Number from the list below. 4. Complete the other information on the form and return it by email or fax as indicated on the form. Keep a copy of the form for your records. When your form is received, Customer Service will contact you and provide an RMA number and directions to return and replace the affected products. Should you have any questions regarding these instructions, please contact Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-6822.