Ultrathane Mac-Loc Locking Loop Multipurpose Drainage… recallZ-2222-2024 · Cook Incorporated · initiated May 15, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Cook Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product labels state the incorrect expiration dates that extends beyond their true expiration date

FDA root cause category: Labeling Change Control

What the company is doing

Cook issued Urgent Medical Device Correction letter mailed via courier to the impacted U.S consignee on 5/16/24. Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected products have been transferred. 2. Examine inventory immediately to determine if you have affected product(s) in your inventory that remain unused. If you have affected product(s) remaining within your inventory: a. You should retain a copy of this letter in an easily accessible location and/or attach a copy of this letter to the affected product. b. You may continue to use affected products. Cook Medical is not requesting product be returned. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]).

Recall details

Recall number: Z-2222-2024
Status: Open, Classified
Initiated by the company: May 15, 2024
Posted by the FDA: Jun 27, 2024
Recalling firm: Cook Incorporated
Quantity: 15 units
Product code: FGE
FDA submissions: K173035
Distribution: MA Foreign: Spain, and Netherlands

Product description

Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230

Code information (models, lots, serial numbers)

UDI: (01)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530

Devices named in this recall

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

Cook G09230
Cook Incorporated · CATHETER, NEPHROSTOMY
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 94696).

Z-2223-2024 · Open, Classified
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephr…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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