5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD
Summary
The FDA issued a Class II for 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Un by Bard Access Systems Inc.. Reason: Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire..
Details
Source
Device Recall
External ID
Z-1994-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Lot/Code Info: Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658
Quantity Affected: 30 kits
Reason for Recall
Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Distribution
U.S. Nationwide distribution in the state of RI.
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-1994-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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