The Recall Desk
ModerateFDA (Devices)·Z-1544-2015·Announced 2015-05-06

Integra Tuohy Needles Recalled for Incorrect Length Labeling

Integra LifeSciences is recalling 90 Tuohy needles that were incorrectly labeled as 5 inches when they are actually 3.5 inches.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding needle length, which is a significant but not immediately life-threatening defect.

Plain-English summary

Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling a single lot of 18 Gauge Tuohy needles. The needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles, but they are actually 18 Gauge, 3.5 inch needles.

The affected product is the Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. The recall involves 90 Tuohy needles (9 cases of 10 each) from Lot No. W1412086, with an expiration date of DEC-2017. The product was distributed nationwide.

These needles are used to administer steroid medication in the epidural space. The FDA has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected needles and contact the manufacturer for instructions.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot No. W1412086
  • Exp DEC-2017.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Integra LifeSciences Corp. d.b.a. Integra Pain Management

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