SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Reported: June 21, 2023 Initiated: April 25, 2023 #Z-1970-2023
Product Description
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
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
Details
- Recalling Firm
- LumiraDx
- Units Affected
- 1003 kits
- Distribution
- US Nationwide distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB. Recalled by LumiraDx. Units affected: 1003 kits.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2023. Severity: Moderate. Recall number: Z-1970-2023.
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