FDA Device Recall Z-1051-2024

Cardinal Health 200, LLC · Waukegan, IL

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

Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

Lot / serial / GTIN: 7946, UDI/DI 20884521029559 (cs), 10884521029552 (ea), Lot Numbers: 2222832064, 2301031864, 2317001864, 2209526164, 2215827064, 2317731864, 2305204964, 2305205064, 2210226764, 2208817764

Quantity: 36300 units

Reason for recall

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Recall record

Recall number: Z-1051-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US and EMEA, Japan, Latin America
Recall initiated: 2023-12-04
Classified by FDA Center: 2024-02-16
FDA published: 2024-02-28
Recalling firm: Cardinal Health 200, LLC
Firm location: Waukegan, IL

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.

‹ All device recalls