Recall Z-1970-2023— LumiraDx
Class II · Ongoing
Class II FDA medical device recall by LumiraDx, initiated 2023-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB. 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 patient may cause injury or medical intervention to remove part of the swab.
- Recalling firm
- LumiraDx
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-25
- Firm location
- Waltham, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.