Lumbar Puncture Trays Recalled for Manometer Leaking and Assembly Defects
Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays due to defects in the manometer component involving leaking and mating issues that could affect device function.
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: This is a FDA Class II recall of a medical device with identified failure modes affecting the manometer component. The defects represent a risk of harm to proper device function during diagnostic procedures. No illnesses or injuries have been reported, which per the rubric limits the score to High for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays (Catalog Number 4306CWDF). These devices have been distributed nationwide in the United States and internationally to Costa Rica and Hong Kong.
The trays are being recalled due to defects in the manometer component involving leaking and mating issues. These failure modes could affect the proper assembly or function of the devices during lumbar puncture procedures.
The affected devices were distributed to healthcare facilities and providers across the United States and to select international locations. The recall includes devices with the following lot numbers: 0001415023, 0001416353, 0001420159, 0001424771, and 0001437270.
Healthcare providers who have received devices with the affected lot numbers should review their inventory and consult with the manufacturer or the FDA for appropriate guidance on replacement or disposal.
The recalled product
- Product
- LUMBAR PUNCTURE DRUG FREE TRAY 22G
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- equipment-malfunction
- leakage
- assembly-defect
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)
- Catalog Number: 4306CWDF Lot Numbers/UDI (GTIN
Distribution
Distributed nationwide across the United States.
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