Summary
The FDA issued a Class II for LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP by Bard Peripheral Vascular Inc. Reason: Due to lumbar puncture tray manometer failure mode of leaking and mating issues..
Details
Source
Device Recall
External ID
Z-0792-2022
Action Date
2022-03-23
Status
Ongoing
Category
device
Product Description
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
Lot/Code Info: Catalog Number: 4301C Lot Numbers/UDI (GTIN, DI + PI): 0001410711 (01)10885403057038(17)220331(10)0001410711 0001411299 (01)10885403057038(17)220331(10)0001411299 0001411867 (01)10885403057038(17)220331(10)0001411867 0001414258 (01)10885403057038(17)220331(10)0001414258 0001414358 (01)10885403057038(17)220331(10)0001414358 0001414359 (01)10885403057038(17)220331(10)0001414359 0001415031 (01)10885403057038(17)220430(10)0001415031 0001415038 (01)10885403057038(17)220430(10)0001415038 0001415850 (01)10885403057038(17)220430(10)0001415850 0001415809 (01)10885403057038(17)220430(10)0001415809 0001417243 (01)10885403057038(17)220430(10)0001417243 0001417244 (01)10885403057038(17)220430(10)0001417244 0001417734 (01)10885403057038(17)220430(10)0001417734 0001418034 (01)10885403057038(17)220430(10)0001418034 0001418308 (01)10885403057038(17)220430(10)0001418308 0001418410 (01)10885403057038(17)220430(10)0001418410 0001421652 (01)10885403057038(17)220630(10)0001421652 0001421921 (01)10885403057038(17)220630(10)0001421921 0001422197 (01)10885403057038(17)220630(10)0001422197 0001422150 (01)10885403057038(17)220630(10)0001422150 0001422604 (01)10885403057038(17)220630(10)0001422604 0001425527 (01)10885403057038(17)220630(10)0001425527 0001425874 (01)10885403057038(17)220630(10)0001425874 0001426189 (01)10885403057038(17)220630(10)0001426189 0001426502 (01)10885403057038(17)220630(10)0001426502 0001427225 (01)10885403057038(17)220630(10)0001427225 0001427380 (01)10885403057038(17)220630(10)0001427380 0001429130 (01)10885403057038(17)220630(10)0001429130 0001429519 (01)10885403057038(17)220630(10)0001429519 0001430121 (01)10885403057038(17)220630(10)0001430121 0001430608 (01)10885403057038(17)220630(10)0001430608 0001431407 (01)10885403057038(17)220630(10)0001431407 0001431472 (01)10885403057038(17)220630(10)0001431472 0001432176 (01)10885403057038(17)220630(10)0001432176 0001432655 (01)10885403057038(17)220831(10)0001432655 0001433601 (01)10885403057038(17)220930(10)0001433601 0001433023 (01)10885403057038(17)220930(10)0001433023 0001434251 (01)10885403057038(17)220930(10)0001434251 0001434730 (01)10885403057038(17)220930(10)0001434730 0001436141 (01)10885403057038(17)220930(10)0001436141 0001437469 (01)10885403057038(17)221031(10)0001437469 0001437660 (01)10885403057038(17)221031(10)0001437660 0001437658 (01)10885403057038(17)221031(10)0001437658 0001437768 (01)10885403057038(17)221031(10)0001437768
Quantity Affected: 116,770 devices
Reason for Recall
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-20
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Peripheral Vascular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bard Peripheral Vascular Inc have FDA actions?
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0792-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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