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Curlin Administration Set recallZ-2053-2019 · Zevex Incorporated (dba MOOG Medical Devices Group) · initiated Feb 27, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zevex Incorporated (dba MOOG Medical Devices Group) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Administration sets leaked at the filter.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The recalling firm issued a letter dated 2/27/2019 via regular mail on 2/272019 to their direct accounts describing the issue, risk to health, and the necessary actions to be taken.

Recall details

Recall number
Z-2053-2019
Status
Terminated
Initiated by the company
Feb 27, 2019
Posted by the FDA
Jul 23, 2019
Recalling firm
Zevex Incorporated (dba MOOG Medical Devices Group)
Quantity
569/20-set caess
Product code
FRN
FDA submissions
K981816
Distribution
Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.

Product description

MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

Code information (models, lots, serial numbers)

Lot numbers CF1819415, CF1820215, CF1821616, CF1822914, and CF1823615, UDI 38148440000464.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 82864).

Sources and updates

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