The Recall Desk
HighFDA (Devices)·Z-0793-2022·Announced 2022-03-23

Adult Lumbar Puncture Drug Free Tray Recalled for Manometer Leaking

Bard Peripheral Vascular Inc is recalling 1,260 Adult Lumbar Puncture Drug Free Trays due to manometer leaking and mating issues that could affect device function.

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 medical device recall for equipment malfunction (manometer leaking and mating issues) with potential to compromise diagnostic procedure safety. No illnesses or injuries have been reported, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 1,260 Adult Lumbar Puncture Drug Free Trays (Catalog Number 4301CDF) due to manometer leaking and mating issues that could affect proper device function.

The affected devices are identified by lot numbers 0001433537 and 0001437269. The manometer is a critical component used to measure cerebrospinal fluid pressure during lumbar puncture procedures, and the reported leaking and mating failures could compromise the procedure's safety and accuracy.

The recalled trays were distributed nationwide throughout the United States, including all states and Puerto Rico, as well as internationally to Costa Rica and Hong Kong.

Healthcare providers who have received these products should stop using affected trays and contact their distributor or Bard Peripheral Vascular Inc directly for return and replacement instructions.

The recalled product

Product
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Diagnostic Equipment
Hazard
  • device-malfunction
  • leaking

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: 4301CDF Lot Numbers/UDI (GTIN

Distribution

Distributed nationwide across the United States.

Related recalls

Same category