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Integra Long Epidural Steroid Injection Needle (Tuohy… recallZ-2056-2015 · Integra LifeSciences Corp. d.b.a. Integra Pain Management · initiated May 1, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corp. d.b.a. Integra Pain Management or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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).

FDA root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number
Z-2056-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 1, 2015
Posted by the FDA
Jul 9, 2015
Recalling firm
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Quantity
123 Tuohy needles
Product code
BSP
FDA submissions
K854816
Distribution
Nationwide Distribution

Product description

Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.

Code information (models, lots, serial numbers)

W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181

Other devices under the same FDA submission

1 device cleared under K854816 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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