The Recall Desk
HighFDA (Devices)·Z-2684-2016·Announced 2016-09-07

Integra Recalls Spinal Trays Due to Lidocaine Component Issue

Integra LifeSciences is recalling specific lots of Spinal Trays because they contain affected Hospira 5% Lidocaine HCL.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medication component (Lidocaine) in a sterile medical device, representing a risk of harm where specific injury reports are not detailed in the source text.

Plain-English summary

Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling the INTEGRA Spinal Tray, Catalogue No. 3404875. The recall involves 200 packages (20 cases) of the sterile spinal trays.

The recall is being conducted because the affected trays contain Hospira 5% Lidocaine HCL, a component that is subject to its own recall. The affected lots were manufactured on February 11, 2015, and July 11, 2015. The specific lot numbers are W1503004, S1501531, and S1505556.

The affected products were distributed in the United States to the states of Ohio and California. There were no foreign, government, VA, or military consignees. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Manufacturer
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Category
Medical Device — Spinal Trays
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)

  • S1501531
  • S1505556

Distribution

Distributed in 2 states:

Related recalls

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