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.
Recall
- Recall Number
- Z-2056-2015
- Event Number
- 71147
- Firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- FEI Number
- 1000138491
- Product Code
- BSP
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- May 1, 2015
- Posted
- July 9, 2015
- Terminated
- December 4, 2015
- Address
- 3498 West 2400 South, # 1050, Salt Lake City, UT, 84119
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.
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.
Nationwide Distribution
123 Tuohy needles