The Recall Desk
ModerateFDA (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.

What this means for you

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: GP
Manufacturer
Cook Incorporated
Category
Medical Device — Drainage Catheter
Hazard
  • incorrect-expiration-date
  • mis-labeling

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:

  • MA

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