The Recall Desk
HighFDA (Devices)·Z-0796-2022·Announced 2022-03-23

Lumbar Puncture Tray Recalled for Manometer Leaking and Connection Issues

Bard Peripheral Vascular is recalling 29,870 lumbar puncture trays due to manometer failure that causes leaking and improper connections. The defect could compromise device function during lumbar puncture 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 an FDA Class II recall with no reported illnesses or injuries. The manometer failure mode—leaking and mating issues—creates a risk of equipment malfunction during lumbar puncture, a high-risk invasive procedure, meeting the rubric criterion for High severity without confirmed patient harm.

Plain-English summary

Bard Peripheral Vascular Inc is recalling Lumbar Puncture Tray Adult 22G X 3.5" Sterile (Catalog Number 4306C) due to manometer failure. Approximately 29,870 devices are affected.

The device's manometer can fail by leaking and developing mating issues—improper connections that prevent proper sealing. These failures could compromise the device during use in lumbar puncture procedures.

The affected devices were distributed nationwide across all U.S. states, Puerto Rico, and internationally to Costa Rica and Hong Kong. Affected lot numbers are available from the FDA.

Healthcare providers and facilities should stop using these trays and contact Bard Peripheral Vascular Inc or the FDA for instructions on return or replacement.

The recalled product

Product
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Diagnostic / Spinal Procedures
Hazard
  • manometer-failure
  • equipment-leakage
  • mating-failure

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: 4306C Lot Numbers/UDI (GTIN

Distribution

Distributed nationwide across the United States.

Related recalls

Same category