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Recall Observatory FDA recall evidence

Device 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

Z-2222-2024

May 15, 2024

Class II

Product summary

Firm
Cook Incorporated
Event
Event 94696
Status
Ongoing
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-2222-2024

Official wording

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

Code information: UDI: (01)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530

Distribution pattern: MA Foreign: Spain, and Netherlands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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