Summary
The FDA issued a Class II for Puritan Bennett 560 Ventilator, PB560, CFN 4096600 by Covidien Llc. Reason: Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufactu.
Details
Source
Device Recall
External ID
Z-1775-2022
Action Date
2022-09-28
Status
Ongoing
Category
device
Product Description
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Lot/Code Info: UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
Quantity Affected: 5 US
Reason for Recall
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
Distribution
Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-19
Company
Mansfield, MA
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 413 device-related FDA actions this month.
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 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 (Covidien Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien Llc have FDA actions?
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1775-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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