SteriPack Sterile Polyester Spun Swabs recalled due to breakage risk
LumiraDx recalled 1,003 kits of SteriPack Sterile Polyester Spun Swabs due to failed post-sterilization testing. Swabs may break in the nasal cavity, potentially causing injury or requiring medical intervention to remove fragments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with demonstrated risk of harm in a sensitive anatomical location (nasal cavity). The swabs fail post-sterilization structural testing and may break during use, potentially causing patient injury or requiring surgical/medical intervention. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario.
Plain-English summary
LumiraDx has recalled SteriPack Sterile Polyester Spun Swabs (Catalog Number 60566RevB) after the swabs failed post-sterilization cantilever (bend) testing. The swabs are more susceptible to breakage than intended, which could result in fragments breaking off during nasal collection.
If a swab breaks in a patient's nasal cavity, it may cause injury or require medical intervention to remove the broken pieces. This risk applies to all affected units.
The recall affects 1,003 kits distributed nationwide in the United States. The affected lot includes Pack Lot Number 85438 and Individual Swab Lot Number 86445, with an expiration date of October 28, 2023.
Healthcare facilities and individuals using these swabs should discontinue use immediately and consult the product manual or contact LumiraDx for instructions on returning affected units or obtaining replacement swabs.
The recalled product
- Product
- SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
- Manufacturer
- LumiraDx
- Hazard
- swab-breakage
- foreign-body-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN-DI: 00850027193205 Pack Lot Number : 85438
- Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023
Distribution
Distributed nationwide across the United States.
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