The Recall Desk
HighFDA (Devices)·Z-0700-2018·Announced 2018-03-07

Moog Curlin Infusion Sets Recalled for Particulate Matter on Spike

Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets because particulate matter was found on the spike. The recall covers 7,979 cases distributed nationwide and internationally.

What this means for you

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: The recall is classified as FDA Class II. The hazard involves particulate matter in a sterile medical device used for infusion, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a High severity score where risk of harm exists without reported injury.

Plain-English summary

Zevex Incorporated (dba Moog Medical Medical Devices Group) is recalling the MOOG Curlin Infusion Administration Set, Reference 340-4166. The recall is due to the discovery of particulate matter on the Curlin spike. The affected product is a sterile, prescription-only administration set used with the Moog Curlin Ambulatory Volumetric Infusion Pump for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

The recall involves 7,979 cases, with each case containing 20 administration sets. Distribution was nationwide, including government and military channels. The product was also distributed to Canada, Saudi Arabia, Turkey, Croatia, the United Arab Emirates, and Australia. Specific lot numbers affected include CF1515305, CF1519505, CF1523004, CF1524405, CF1529201, CF1528602, CF1532105, CF1601204, CF1604701, CF1605403, CF1609005, CF1609604, and CF1614732.

Healthcare providers and consumers should stop using the affected infusion sets and contact Zevex Incorporated for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Admini

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 (14)

  • UDI 38148440000563
  • Lot/serial numbers: CF1515305
  • CF1519505
  • CF1523004
  • CF1524405
  • CF1529201
  • CF1528602
  • CF1532105
  • CF1601204
  • CF1604701
  • CF1605403
  • CF1609005
  • CF1609604
  • and CF1614732.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Zevex Incorporated (dba Moog Medical Medical Devices Group) 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 6 products in this recall →

Same manufacturer · Zevex Incorporated (dba Moog Medical Medical Devices Group)

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