Integra Recalls Single Shot Epidural Trays Missing Injectable Components
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays because they were shipped without required injectable components.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a missing component (packaging/kit completeness) rather than a contamination or active defect.
Plain-English summary
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling one lot of Single Shot Epidural Trays, Sterile. The recall involves 40 units (4 cases x 10 units per case) of Model number 3403644, Lot W1112119. These trays are intended to provide sterile instruments, drugs, and other medical materials to support the administration of spinal anesthesia by licensed medical professionals.
The recall was initiated because the product was inadvertently shipped missing injectable components. The affected units were distributed nationwide, including Massachusetts.
Healthcare facilities and consumers should check their inventory for Single Shot Epidural Trays with Lot W1112119. If found, these units should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical pro
- Category
- Medical Device — Surgical Kits
- 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 (1)
- Lot W1112119
Distribution
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