Drainage Catheter Recalled Due to Incorrect Expiration Dates on Labels
Cook Incorporated is recalling 15 units of the Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter due to incorrect expiration dates on product labels that extend beyond the device's true expiration date. Affected units were distributed to Spain and the Netherlands.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with mislabeled expiration dates on a sterile drainage catheter. No reported injuries or illnesses, but expired medical devices pose genuine risk of infection and device failure. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cook Incorporated is recalling 15 units of the Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter (model ULT16.0-38-25-P-6S-MCL-HC, lot NS15924530). This catheter is designed for percutaneous drainage in applications including nephrostomy, biliary drainage, and abscess drainage, using either direct stick or Seldinger access technique.
The recall was issued because the product labels state incorrect expiration dates that extend beyond the device's true expiration date. An expired catheter may not maintain the required sterility and performance standards necessary for safe patient care.
The affected units were distributed to Spain and the Netherlands. The product UDI is (01)00827002092303(17)270228(10)NS15924530 and the lot number is NS15924530.
The recalled product
- 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…
- Manufacturer
- Cook Incorporated
- 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)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530
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.
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