Recall Z-2222-2024— Cook Incorporated

Name: FDA recall Z-2222-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-15

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2024-05-15. It names one FDA 510(k) clearance: K173035. 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. Reason: Product labels state the incorrect expiration dates that extends beyond their true expiration date.

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2024-05-15
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K173035 — Gordon 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

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.