Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2223-2024·Announced 2024-07-03

Cook Drainage Catheter Recall: Incorrect Expiration Date Labels

Cook Incorporated is recalling 15 units of a multipurpose drainage catheter due to product labels stating incorrect expiration dates that extend beyond the devices' true expiration, creating a risk of expired device use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall involving labeling errors (incorrect expiration dates). While the discrepancy creates a theoretical risk of using expired devices, no illnesses or injuries have been reported in the source text.

Plain-English summary

Cook Incorporated is recalling the Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter (Lot Number 15923728) due to labeling that states incorrect expiration dates. The product labels show expiration dates that extend beyond the true expiration date of the devices.

The affected drainage catheter is intended for percutaneous drainage applications, including nephrostomy, biliary, and abscess drainage. A total of 15 units have been identified with this labeling discrepancy and were distributed to Spain and the Netherlands.

The primary risk is that healthcare providers could use devices past their true expiration date based on the incorrect label information. No illnesses or injuries have been reported in connection with this recall. Customers who received affected units should contact Cook Incorporated to verify the correct expiration date for their product lot or arrange for replacement.

The recalled product

Product: 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., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER…
Manufacturer: Cook Incorporated
Category: Medical Device — Drainage Catheter
Hazard: incorrect-expiration-date
mis-labeling
Affected units: 15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI: (01)00827002097674(17)270228(10)15923728 Lot Number: 15923728

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Moderate
Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
Critical
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
Severe
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
High
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15

Same hazard · incorrect expiration date