SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catal

FDA device recall Z-1970-2023 · posted 2023-06-15 · Open, Classified

Recall details

Recalling firm

LumiraDx

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

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

Root cause

Process control

Status

Open, Classified

Product code

KXG

Quantity affected

1003 kits

Distribution

US Nationwide distribution.

Date initiated

2023-04-25

Date posted

2023-06-15

Location

Waltham, MA