The Recall Desk
HighFDA (Devices)·Z-0791-2022·Announced 2022-03-23

Lumbar Puncture Tray Pediatric Recalled Due to Manometer Failure

Bard Peripheral Vascular Inc is recalling pediatric lumbar puncture trays due to manometer leaking and mating failures that could prevent proper pressure measurement during procedures.

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 Class II device recall involving a manometer failure in a pediatric lumbar puncture tray. While no illnesses or injuries have been reported, the device defect poses a risk of harm in an invasive medical procedure, meeting the criterion for High severity.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 11,970 pediatric lumbar puncture trays (Catalog Number 4304C) distributed across the United States, Puerto Rico, Costa Rica, and Hong Kong.

The manometer in the tray is experiencing leaking and mating failures that prevent proper equipment function. These defects could compromise the tray's ability to accurately measure cerebrospinal fluid pressure during lumbar puncture procedures.

Healthcare facilities in the affected distribution areas that received these devices should stop using them immediately. The recall affects multiple lot numbers manufactured between March 2022 and October 2022.

Affected institutions should contact Bard Peripheral Vascular Inc or the FDA for replacement devices or disposal instructions.

The recalled product

Product
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Diagnostic / Procedural
Hazard
Affected units
11,970

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: 4304C Lot Numbers/UDI (GTIN

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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.

See all 11 products in this recall →

Related recalls

Same manufacturer · Bard Peripheral Vascular Inc

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Same hazard · manometer leak

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