FDAClass IIMarch 23, 2022

Lumbar Puncture Drug Free Tray recall

LUMBAR PUNCTURE DRUG FREE TRAY 22G

Why was Lumbar Puncture Drug Free 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: 4306CWDF Lot Numbers/UDI (GTIN, DI + PI): 0001415023 (01)10885403231827(17)250731(10)0001415023 0001416353 (01)10885403231827(17)250731(10)0001416353 0001420159 (01)10885403231827(17)250731(10)0001420159 0001424771 (01)10885403231827(17)250731(10)0001424771 0001437270 (01)10885403231827(17)250731(10)0001437270

Product
LUMBAR PUNCTURE DRUG FREE TRAY 22G
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