Events

Recall of Device Recall Curlin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Curlin Medical Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38341
  • Event Risk Class
    Class 2
  • Event Number
    Z-1129-2007
  • Event Initiated Date
    2007-02-09
  • Event Date Posted
    2007-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53460
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    IV Administration Sets - Product Code FPA
  • Reason
    The administration sets may leak at the reservior bag.
  • Action
    A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels. A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet acceptable performance levels.

Device

Device Recall Curlin
  • Model / Serial
    Model Numbers 340-4111- Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109
  • Product Description
    Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
  • Manufacturer
    Curlin Medical Llc

Manufacturer

Curlin Medical Llc
  • Manufacturer Address
    Curlin Medical Llc, 15751 Graham St, Huntington Beach CA 92649-1630
  • Source
    USFDA