FDA Recalls SAFE-T PLUS Lumbar Puncture Trays for Device Malfunction
Bard Peripheral Vascular is recalling 49,760 SAFE-T PLUS lumbar puncture trays for adults due to manometer leaking and mating issues. Healthcare providers should discontinue use and contact the manufacturer.
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: This is an FDA Class II recall of a diagnostic medical device with malfunction risks that could compromise clinical function. The source text does not report any hospitalizations, injuries, or deaths, so per the rubric this is classified as High rather than Severe.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the SAFE-T PLUS Lumbar Puncture Tray (Adult), a medical device used during lumbar puncture procedures. The recall affects 49,760 devices distributed nationwide across the United States, Puerto Rico, Costa Rica, and Hong Kong.
The devices are being recalled due to manometer failure modes, specifically leaking and mating issues. These defects can prevent the manometer from functioning properly, potentially affecting the accuracy of pressure readings during procedures.
Healthcare providers and facilities with affected devices should verify their inventory against the provided lot numbers, discontinue use of affected units, and contact Bard Peripheral Vascular for guidance on replacement or disposal.
The recalled product
- Product
- SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 49,760
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: 4301CSP Lot Numbers/UDI (GTIN
Distribution
Part of a larger recall action
This product is one of 11 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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