FDAClass IIMarch 23, 2022

Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray recall

Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer

Why was Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray recalled?

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 4302CSP Lot Numbers/UDI (GTIN, DI + PI): 0001412493 (01)10885403107788(17)220331(10)0001412493 0001415324 (01)10885403107788(17)220430(10)0001415324 0001416351 (01)10885403107788(17)220430(10)0001416351 0001417052 (01)10885403107788(17)220430(10)0001417052 0001417550 (01)10885403107788(17)220430(10)0001417550 0001421010 (01)10885403107788(17)220531(10)0001421010 0001422378 (01)10885403107788(17)220630(10)0001422378 0001425085 (01)10885403107788(17)220630(10)0001425085 0001426188 (01)10885403107788(17)220630(10)0001426188 0001426941 (01)10885403107788(17)220630(10)0001426941 0001428873 (01)10885403107788(17)220630(10)0001428873 0001431044 (01)10885403107788(17)220630(10)0001431044 0001433024 (01)10885403107788(17)220831(10)0001433024 0001433846 (01)10885403107788(17)220930(10)0001433846 0001437468 (01)10885403107788(17)221031(10)0001437468 0001438331 (01)10885403107788(17)221031(10)0001438331 0001439310 (01)10885403107788(17)221031(10)0001439310 0001440531 (01)10885403107788(17)221031(10)0001440531

Product
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
Recalling firm
Bard Peripheral Vascular Inc
Quantity
20,400 devices
Distribution
U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
Recall date
March 23, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls