Z-1970-2023 Class II Ongoing

Recalled by LumiraDx — Waltham, MA

Recall Details

Product Type
Devices
Report Date
June 21, 2023
Initiation Date
April 25, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1003 kits

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

Distribution Pattern

US Nationwide distribution.

Code Information

GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023