FDAClass IIMarch 23, 2022

Safe-t Plus Atraumatic Adult LP Tray recall

SAFE-T PLUS ATRAUMATIC ADULT LP TRAY

Why was Safe-t Plus Atraumatic Adult LP 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: 4306CWSP Lot Numbers/UDI (GTIN, DI + PI): 0001416832 (01)10885403229008(17)220430(10)0001416832 0001417843 (01)10885403229008(17)220430(10)0001417843 0001421009 (01)10885403229008(17)220531(10)0001421009 0001424764 (01)10885403229008(17)220630(10)0001424764 0001428872 (01)10885403229008(17)220630(10)0001428872 0001436145 (01)10885403229008(17)220930(10)0001436145

Product
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Recalling firm
Bard Peripheral Vascular Inc
Quantity
3,240 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