FDA Recalls Adult Lumbar Puncture Trays for Manometer and Connector Defects
Bard Peripheral Vascular is recalling 116,770 adult lumbar puncture trays due to manometer leaks and connector mating defects that could affect procedure performance.
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: FDA Class II designation indicates serious potential hazard. The device exhibits actual failure modes (manometer leaking and connector mating defects) affecting critical pressure measurement function in an invasive medical procedure. No illnesses or injuries have been reported.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling 116,770 adult lumbar puncture trays (Catalog Number 4301C). These sterile medical devices are used to assist in spinal fluid collection procedures.
The recall is due to a manometer failure mode that can result in leaking and connector mating defects, potentially affecting the pressure measurement system used during the procedure. Affected lot numbers and UDI information are available on the FDA website.
The affected devices were distributed nationwide in the United States, Puerto Rico, and internationally to Costa Rica and Hong Kong. Healthcare providers currently using these devices should contact Bard Peripheral Vascular Inc. for instructions regarding return, replacement, or disposal of affected units.
The recalled product
- Product
- LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- manometer-leak
- connector-mating-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: 4301C Lot Numbers/UDI (GTIN
Distribution
Distributed nationwide across the United States.
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