Hilal recallZ-1240-2022 · Cook Incorporated · initiated May 5, 2022

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On May 5, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were advised that the presence of a small stainless steel cannula inside the loading cartridge may go undetected by the user. Customers were instructed to examine their inventory and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. Customers should return the product to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Please share this information with appropriate personnel, down to the user level, within your organization or with any organization where the affected devices may have been transferred. Physicians should practice their standard patient monitoring following the procedure for an early identification of any complications to mitigate their severity. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Recall details

Recall number

Z-1240-2022

Status

Open, Classified

Initiated by the company

May 5, 2022

Recalling firm

Cook Incorporated

Quantity

106,033

Product code

KRD

FDA submissions

K160219

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Product description

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Hilal G47498

  Cook Incorporated · Device, Vascular, for Promoting Embolization
  1 recall0 reports
• Hilal G47499

  Cook Incorporated · Device, Vascular, for Promoting Embolization
  1 recall0 reports

Product lines

• HilalCook Incorporated · 2 models · 0 reports · 1 recall

Other products in the same recall event

The FDA groups related products into one recall event (event 90103).

• Z-1241-2022 · Open, Classified
  Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTE…
• Z-1242-2022 · Open, Classified
  Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWC…