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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 8,630
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
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.
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