FDA Recalls Safe-T PLUS Pediatric Lumbar Puncture Tray Due to Manometer Failure
Bard Peripheral Vascular Inc is recalling 20,400 Safe-T PLUS pediatric lumbar puncture trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally to healthcare facilities.
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: FDA Class II medical device with potential failure modes (leaking and mating issues) affecting a critical measurement component used in pediatric spinal procedures. No reported injuries or illnesses documented. Classified as a risk-of-harm product where actual injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray with 22 gauge x 1.5 inch spinal needle and manometer. A total of 20,400 devices are affected by this recall.
The devices are being recalled due to manometer failure modes involving leaking and mating issues. These failures could potentially impact the accuracy and functionality of the device during lumbar puncture procedures in pediatric and infant patients.
The affected devices were distributed nationwide throughout the United States, including all 50 states, the District of Columbia, and Puerto Rico, as well as internationally to Costa Rica and Hong Kong. Healthcare facilities that received these devices may have affected trays in inventory.
Healthcare facilities and users in possession of affected Safe-T PLUS trays should discontinue use and contact Bard Peripheral Vascular Inc for instructions on device return or replacement. Affected devices can be identified by catalog number 4302CSP and the specific lot numbers referenced in the FDA recall notice.
The recalled product
- Product
- Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- manometer-failure
- leakage
- connection-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: 4302CSP Lot Numbers/UDI (GTIN
Distribution
Distributed nationwide across the United States.
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