Device product
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.
Z-2056-2015
Product summary
- Event
- Event 71147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 123 Tuohy needles
- Official record key
device-enforcement:Z-2056-2015
Official wording
Reason: 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).
Code information: W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Labeling or packaging
incorrect packaging