SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Cata
Summary
The FDA issued a Class II for SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample coll by LumiraDx. Reason: Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a .
Details
Source
Device Recall
External ID
Z-1970-2023
Action Date
2023-06-21
Status
Ongoing
Category
device
Product Description
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Lot/Code Info: GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023
Quantity Affected: 1003 kits
Reason for Recall
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-25
Company
Waltham, 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 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LumiraDx has 4 FDA actions in our database, including 4 recalls.
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 (LumiraDx) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LumiraDx have FDA actions?
LumiraDx has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1970-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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