smiths medical portex Loss of Resistance Device, REF 100/398/000
Summary
The FDA issued a Class II for smiths medical portex Loss of Resistance Device, REF 100/398/000 by Smiths Medical ASD Inc.. Reason: The labeling was missing information on sterilization and prohibition of reuse..
Details
Source
Device Recall
External ID
Z-0152-2022
Action Date
2021-10-27
Status
Terminated
Category
device
Product Description
smiths medical portex Loss of Resistance Device, REF 100/398/000
Lot/Code Info: Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
Quantity Affected: 3420 devices
Reason for Recall
The labeling was missing information on sterilization and prohibition of reuse.
Distribution
Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
Type: Voluntary: Firm initiated
Recall Initiated: 2020-12-08
Company
Minneapolis, MN
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 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 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 (Smiths Medical ASD Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD Inc. have FDA actions?
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0152-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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