Integra Recalls Spinal Tray Kits Missing Needle Introducer
Integra LifeSciences is recalling 320 packages of Spinal Tray 24G Gertie Marx kits because one lot was shipped without the required needle introducer.
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. The hazard involves a missing component (introducer) in a medical kit, which is a significant defect but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling 320 packages of the PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. The recall affects Lot Number W1503532, which was distributed to California.
The recall was initiated because the company identified that the affected lot was shipped containing the 24G Gertie Marx needle without an introducer. The product is intended to provide licensed medical professionals with a kit containing drugs and other medical devices used to support the administration of general and local anesthetics.
No specific instructions for consumers are provided in the source text, as the product is intended for licensed medical professionals.
The recalled product
- Product
- PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 320
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 (1)
- Lot Number affected: W1503532
Distribution
Distributed in 1 state:
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