Integra LifeSciences Corp. d.b.a. Integra Pain Management

Lot No. W1412086, Exp DEC-2017.

Anesthesiology Devices

2

No

Nationwide Distribution.

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.

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

Anesthesiology Devices

2

No

Nationwide Distribution

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.

167450, 172960, 175720, 177188, 178547, 182130.

Neurological Devices

2

No

(USA) Nationwide Distribution

1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. || Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.

167449, 175178, 178317, 178902, 183073.

Neurological Devices

2

No

(USA) Nationwide Distribution

31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. || Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.

W1003222, W1005153, W1006110, W1010082, W1103148, W1108088, W1108227.

Neurological Devices

2

No

(USA) Nationwide Distribution

Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. || Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.