5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC
Summary
The FDA issued a Class II for 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: by Bard Access Systems Inc.. Reason: Catheter kits contained the incorrect micro-introducers..
Details
Source
Device Recall
External ID
Z-1991-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Lot/Code Info: Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201
Quantity Affected: 180 units
Reason for Recall
Catheter kits contained the incorrect micro-introducers.
Distribution
U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-19
Company
Salt Lake City, UT
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 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bard Access Systems Inc. has 11 FDA actions in our database, including 4 recalls and 7 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 Access Systems 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 Access Systems Inc. have FDA actions?
Bard Access Systems Inc. has 11 FDA actions in our database, including 4 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1991-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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