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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Category
- Medical Device — Needles
- Hazard
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.
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