Recall Z-1970-2023 ยท KXG Applicator, Absorbent Tipped, Sterile
LumiraDx
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
| Date | Jun 15, 2023 (initiated Apr 25, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| Action | LumiraDx issued on 25 April 2023 via email electronic Cover Letter and Urgent Product Recall Notice with an attestation form to document product destruction at their facility. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lot of swabs " Remove from your stock any remaining affected kits of swabs. " Destroy all stock of affected swabs " Indicate the number of packs that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected swabs in your inventory. " Report any issues or adverse events |
| Quantity | 1003 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.