Z-1544-2015Class II

Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal...

Name: Z-1544-2015 Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2015-03-30
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2015-03-30 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850... on 2015-03-30. FDA classified it as Class II and gives the reason as "A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1544-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-30
Posted: 2015-04-29
Terminated: 2015-06-24
Recalling firm: Integra Pain Management
Product: Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 90 Tuohy needles (9 cases of 10 each)
Distribution: Nationwide Distribution.
Product codes and lots: Lot No. W1412086, Exp DEC-2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1544-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-28

Product code BSP

K854816Class IIEpidural Anesthesia NeedlesReganes, Inc. / cleared 1985-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)