REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Summary
The FDA issued a Class II for REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, by Bard Peripheral Vascular Inc. Reason: There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the fo.
Details
Source
Device Recall
External ID
Z-1273-2022
Action Date
2022-06-29
Status
Ongoing
Category
device
Product Description
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Lot/Code Info: Lot # 0001405396; UDI/DI: (01)10885403076114
Quantity Affected: 1460 units
Reason for Recall
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Distribution
Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-22
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 107 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-1273-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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