Z-2056-2015 Class II Terminated
FDA device recall Z-2056-2015 was initiated by Integra LifeSciences Corp. d.b.a. Integra Pain Management on May 1, 2015 and is designated Class II. 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). The recall status is terminated (terminated December 4, 2015). Affected quantity: 123 Tuohy needles.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2015
- Initiation Date
- May 1, 2015
- Termination Date
- December 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 Tuohy needles
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.
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).
Distribution Pattern
Nationwide Distribution
Code Information
W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181