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FDA (Device enforcement)Recalled 2023-04-25class ii

LumiraDx: SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB

Hazard

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

Details from the source

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. Quantity: 1003 kits Lot/code info: GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023

UPC codes

00850027193205

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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