Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibration

FDA device recall Z-2056-2015 · posted 2015-07-09 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp. d.b.a. Integra Pain Management

Reason for recall

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).

Action taken

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.

Root cause

Labeling design

Status

Terminated

Product code

BSP

Quantity affected

123 Tuohy needles

Distribution

Nationwide Distribution

Date initiated

2015-05-01

Date posted

2015-07-09

Date terminated

2015-12-04

Location

Salt Lake City, UT

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