Summary
The FDA issued a Class II for ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G 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-0793-2022
Action Date
2022-03-23
Status
Ongoing
Category
device
Product Description
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Lot/Code Info: Catalog Number: 4301CDF Lot Numbers/UDI (GTIN, DI + PI): 0001433537 (01)10885403231810(17)260831(10)0001433537 0001437269 (01)10885403231810(17)260930(10)0001437269
Quantity Affected: 1260 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-0793-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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