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Open, Classified

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

FDA Recall Z-2222-2024 · Posted 2024-06-27

Recalling FirmCook Incorporated
Recall StatusOpen, Classified
Product CodeFGE
Date Initiated2024-05-15
Product Quantity15 units

Reason for Recall

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

Firm Action

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]).

Root Cause

Labeling Change Control

Distribution Pattern

MA Foreign: Spain, and Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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