FDA Device Recall Z-0323-2023

DEWEI MEDICAL EQUIPMENT CO LTD · Foshan, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

Lot / serial / GTIN: LOT / EXP DW200628 27-Jun-21 DW200520 19-May-21 DW200520 19-May-21 DW201202 01-Dec-21 DW201202 1-Dec-21 DW210103 2-Dec-22 DW210926 25-Sep-22

Quantity: 1,348,000 (US)

Reason for recall

Products were distributed in the United States without FDA authorization or clearance.

Recall record

Recall number: Z-0323-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Other
Distribution: US Distribution in states to: CA, FL, KY, and MI.
Recall initiated: 2022-08-09
Classified by FDA Center: 2022-12-07
FDA published: 2022-12-14
Recalling firm: DEWEI MEDICAL EQUIPMENT CO LTD
Firm location: Foshan, N/A, China

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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