Z-2222-2024Class II

Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for...

Name: Z-2222-2024 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for...
Creator: Cook Incorporated
Published: 2024-05-15
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2024-05-15 / Open, Classified / root cause: labeling and UDI

FDA source

Cook Incorporated began a recall of 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... on 2024-05-15. FDA classified it as Class II and gives the reason as "Product labels state the incorrect expiration dates that extends beyond their true expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2222-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-15
Posted: 2024-06-27
Recalling firm: Cook Incorporated
Product: 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
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Product labels state the incorrect expiration dates that extends beyond their true expiration date
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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]).
Quantity in commerce: 15 units
Distribution: MA Foreign: Spain, and Netherlands
Product codes and lots: UDI: (01)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2222-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2222-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-27
Z-2223-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-27

Product code FGE

K173035Class IIGordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and SetsCook Incorporated / cleared 2018-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)