SAFE-T PLUS Adult Lumbar Puncture Tray recalled for manometer failure
Bard Peripheral Vascular Inc recalled 3,240 SAFE-T PLUS Adult lumbar puncture trays due to manometer failures involving leaking and defective mating connections.
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: FDA Class II recall for device malfunction with no reported illnesses or injuries. The manometer failure and mating issues represent a risk-of-harm from a defective medical device used in an invasive diagnostic procedure.
Plain-English summary
Bard Peripheral Vascular Inc recalled 3,240 SAFE-T PLUS ATRAUMATIC ADULT LP TRAY devices (Catalog Number 4306CWSP) due to manometer failures. The affected devices can leak or experience defective mating connections that prevent proper assembly.
The recalled devices were distributed nationwide throughout the United States, Puerto Rico, Costa Rica, and Hong Kong. Affected lot numbers include: 0001416832, 0001417843, 0001421009, 0001424764, 0001428872, and 0001436145.
This is a Class II FDA recall. Healthcare facilities and medical providers with these devices should contact Bard Peripheral Vascular Inc or the FDA for guidance on the appropriate course of action.
The recalled product
- Product
- SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Lumbar Puncture
- Affected units
- 3,240
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: 4306CWSP 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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