Integra Bone Marrow Biopsy Trays Recalled Due to Lidocaine Particulate
Integra is recalling Bone Marrow Biopsy Trays because they contain Hospira Lidocaine vials with visible particulate matter.
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 3/5 (High).
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 involves a medical device with a confirmed complaint of visible particulate matter in an injectable component, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling Bone Marrow Biopsy Trays (Catalogue No. 3404253) because they include vials of 1% Lidocaine HCL Injection, USP, 10 mg/mL, that are subject to a separate recall by Hospira Inc. The Hospira recall is due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial of Lidocaine, Lot 44-359-DK.
The affected Integra trays were distributed to the state of Maryland. A total of 470 packages (47 cases) are involved. The recall covers three Integra lot numbers: W1501193, W1504141, and W1505078. These trays contain various medical devices and components for bone marrow biopsies, sealed in EtO sterilizable pouches, along with the affected Lidocaine vials in separate sealed pouches.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected trays. Patients who have already received a biopsy using these trays should contact their healthcare provider if they have concerns or experience adverse effects.
The recalled product
- Product
- Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and…
- Category
- Medical Device — Biopsy Trays
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)
- W1504141
- W1505078 Catalogue No. 3404253
Distribution
Distributed in 1 state:
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