CLASS II ONGOING Device recall · Reported 21 Jun 2023 · FDA Enforcement Report
SteriPack Sterile Polyester Spun Swabs/Pack)- Intended recalled
LumiraDx is recalling SteriPack Sterile Polyester Spun Swabs/Pack)- Intended for sample collection in the, distributed nationwide in the US. The recall was initiated on 25 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1970-2023
- FDA event ID
- 92334
- Recalling firm
- LumiraDx, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Apr 2023
- FDA classified
- 15 Jun 2023
- Reported
- 21 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2023 | Recall initiated by company | |
| 15 Jun 2023 | Classified by FDA | +51 days |
| 21 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is SteriPack Sterile Polyester Spun Swabs/Pack)- Intended for sample collection in the recalled?
Yes. LumiraDx recalled SteriPack Sterile Polyester Spun Swabs/Pack)- Intended for sample collection in the on 25 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1970-2023.
Why was it recalled?
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
Which lots are affected?
GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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