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.
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 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
- Category
- Medical Device
- Affected units
- 2,880
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
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.
See all 11 products in this recall →Related recalls
Same manufacturer · Bard Peripheral Vascular Inc
See all →- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
- HighDrainage catheter trays recalled over safety indicators showing the wrong position
FDA (Devices) · 2025-12-17
- ModerateVein ablation generators recalled over software falsely flagging working catheters
FDA (Devices) · 2025-10-08
- CriticalRotarex Atherectomy Catheter Recalled for Helix Fracture Risk
FDA (Devices) · 2025-03-12
Same hazard · manometer failure
See all →- CriticalManual resuscitators recalled because blocked manometer port may disable pressure gauge
FDA (Devices) · 2025-08-20
- HighSAFE-T PLUS Adult Lumbar Puncture Tray recalled for manometer failure
FDA (Devices) · 2022-03-23
- HighLumbar Puncture Tray Adult recalled due to manometer failure and leaking
FDA (Devices) · 2022-03-23
- HighLumbar Puncture Tray Recalled for Manometer Leaking and Connection Issues
FDA (Devices) · 2022-03-23
- HighFDA Recalls Safe-T PLUS Pediatric Lumbar Puncture Tray Due to Manometer Failure
FDA (Devices) · 2022-03-23
Similar recalls
- ModerateSmiths Medical Recalls Mislabeled Portex Lumbar Puncture Trays
FDA (Devices) · 2020-05-06
- SevereCustomed Wound Management Tray Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Wound Management Trays Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- ModerateBusse Lumbar Puncture Tray Recalled for Foreign Matter
FDA (Devices) · 2018-02-14
- SevereCustomed Wound Management Tray Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- ModerateBard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
FDA (Devices) · 2019-02-13