The Recall Desk
HighFDA (Devices)·Z-0795-2022·Announced 2022-03-23

Lumbar Puncture Tray Adult recalled due to manometer failure and leaking

Bard Peripheral Vascular Inc is recalling 8,630 lumbar puncture trays due to manometer failure causing leaking and mating issues. Devices were distributed nationwide in the U.S. plus Puerto Rico, Costa Rica, and Hong Kong.

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 for a medical device with manometer failure involving leaking and mating issues. The source does not report any illnesses or injuries. Per the severity rubric, this qualifies as a risk-of-harm product without reported injury, meriting a High (3) score.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 8,630 Lumbar Puncture Tray Adult 18G x 3.5 devices with catalog number 4303C. The affected devices were distributed nationwide across all U.S. states and territories, including Puerto Rico, as well as Costa Rica and Hong Kong.

The FDA issued a Class II recall for these devices due to a manometer failure mode characterized by leaking and mating issues.

Multiple lot numbers have been identified as affected in this recall. The complete list of affected lot numbers and their corresponding UDI codes are documented in the FDA recall notice.

The recalled product

Product
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Procedural Equipment
Hazard
  • manometer-failure
  • leaking
  • mating-issues

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: 4303C Lot Numbers/UDI (GTIN

Distribution

Distributed nationwide across the United States.

Related recalls

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