FDAClass IIMarch 23, 2022

Atraumatic Adult Lumbar Puncture Tray recall

ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY

Why was Atraumatic Adult 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: 4306CW Lot Numbers/UDI (GTIN, DI + PI): 0001415028 (01)10885403228995(17)220430(10)0001415028 0001417842 (01)10885403228995(17)220430(10)0001417842 0001424355 (01)10885403228995(17)220630(10)0001424355 0001431413 (01)10885403228995(17)220630(10)0001431413 0001436376 (01)10885403228995(17)220930(10)0001436376

Product
ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
Recalling firm
Bard Peripheral Vascular Inc
Quantity
2,880 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