Cook Incorporated: Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Is my product affected?

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

• UPC 00827002474994
• UPC 00827002474987

Check against the official notice below — it lists the full affected range.

What happened

Cook Incorporated is recalling Hilal Embolization Microcoil devices (model numbers RPN MWCE-18-1.0-0-HILAL-01 and RPN MWCE-18-0.5-0-HILAL-01) because the loading cartridges included with these devices may contain a small, unintended stainless-steel cannula. Approximately 106,033 units have been distributed both domestically nationwide and internationally worldwide across 17 affected lot numbers.

The recall record does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Details from the source

Reason for recall: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 106,033 Lot/code info: Lots: 14212811 14215685 14212247 14212812 14212814 14215682 14361413 14361416 14285326 14285328 14285330 14297289 14361412 14445407 14444454 14477949 14477950 UDI: (01)00827002474994(17)261013(10)14212811 (01)00827002474994(17)261008(10)14215685 (01)00827002474987(17)261011(10)14212247 (01)00827002474987(17)261008(10)14212812 (01)00827002474994(17)261008(10)14212814 (01)00827002474994(17)261008(10)14215682 (01)00827002474994(17)261219(10)14361413 (01)00827002474994(17)261220(10)14361416 (01)00827002474987(17)261110(10)14285326 (01)00827002474987(17)261110(10)14285328 (01)00827002474994(17)261110(10)14285330 (01)00827002474994(17)261123(10)14297289 (01)00827002474987(17)261220(10)14361412 (01)00827002474987(17)270207(10)14445407 (01)00827002474994(17)270207(10)14444454 (01)00827002474987(17)270217(10)14477949 (01)00827002474994(17)270216(10)14477950

Source

Official record: FDA (Device enforcement) ↗

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

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