Lumbar Puncture Tray Devices Recalled for Manometer Leaking and Mating Issues
Bard Peripheral Vascular Inc. recalls SAFE-T PLUS lumbar puncture trays due to manometer leaking and mating issues affecting device function. The FDA Class II recall covers 15,650 devices distributed nationwide and internationally.
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 recall of a medical device with a functional defect (manometer leaking and mating issues) that could compromise proper procedure performance. No illnesses or injuries are reported in the source, aligning with the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling SAFE-T PLUS Lumbar Puncture Tray Adult devices due to manometer failure involving leaking and mating issues. The manometer is responsible for measuring cerebrospinal fluid pressure during lumbar puncture procedures.
The recall affects 15,650 devices distributed nationwide across all U.S. states and Puerto Rico, as well as internationally in Costa Rica and Hong Kong. Affected devices are identified by catalog number 4306CSP and specific lot numbers listed in the FDA recall notice.
Healthcare providers and facilities should contact Bard Peripheral Vascular Inc. for information on replacing or returning affected devices.
The recalled product
- Product
- SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device
- Hazard
- leaking
- mating-failure
- device-malfunction
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: 4306CSP Lot Numbers/UDI (GTIN
Distribution
Distributed nationwide across the United States.
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