Device product
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Z-1970-2023
Product summary
- Firm
- LumiraDx
- Event
- Event 92334
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1003 kits
- Official record key
device-enforcement:Z-1970-2023
Official wording
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
Code information: GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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