SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
- Company
- Lumiradx
- Recall Initiated
- April 25, 2023
- Posted
- June 15, 2023
- Recall Number
- Z-1970-2023
- Quantity
- 1003 kits
- Firm Location
- Waltham, MA
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
Distribution
US Nationwide distribution.
Lot / Code Info
GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023
Root Cause
Process control
Action Taken
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 with using the affected swabs to LumiraDx immediately or to the FDA via the MedWatch program. " Please forward this notice to additional testing sites if these products were further distributed within your system. " LumiraDx will provide replacement product after receipt of the attestation form. Please contact CustomerServices.US@LumiraDx.com to arrange overnight shipment. Please complete and return the enclosed product destruction and attestation form to LumiraDx as soon as possible. If you have any questions, contact LumiraDx Technical Services at Technicalservices.US@lumiradx.com or 1-888-586-4721 option 1