The Recall Desk
HighFDA (Devices)·Z-0798-2022·Announced 2022-03-23

Atraumatic Adult Lumbar Puncture Tray Recalled Due to Manometer Leaking and Mating Issues

Bard Peripheral Vascular Inc. is recalling 2,880 Atraumatic Adult Lumbar Puncture Trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally.

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 a functional defect (manometer leaking and mating failure). No illnesses or injuries are reported in the source text, but the defect poses a risk of harm to users.

Plain-English summary

Bard Peripheral Vascular Inc. is recalling 2,880 Atraumatic Adult Lumbar Puncture Trays (Catalog Number 4306CW) due to manometer leaking and mating issues.

The recalled trays were distributed throughout the United States, as well as to Costa Rica and Hong Kong. The affected lot numbers are: 0001415028, 0001417842, 0001424355, 0001431413, and 0001436376.

Hospitals and healthcare facilities with these devices should contact Bard Peripheral Vascular Inc. for information about the recall. Consumers who have questions about whether they have affected devices should verify the lot number on their product and contact the manufacturer.

The recalled product

Product
ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
Manufacturer
Bard Peripheral Vascular Inc
Hazard
  • manometer-failure
  • leaking
  • 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: 4306CW Lot Numbers/UDI (GTIN

Distribution

Distributed nationwide across the United States.