Events

Recall of Device Recall NIPRO, GLUCOPRO INSULIN SYRINGES

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

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
    54358
  • Event Risk Class
    Class 2
  • Event Number
    Z-1103-2010
  • Event Initiated Date
    2010-01-13
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88327
  • 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
    Disposable Insulin Syringe - Product Code FMF
  • Reason
    Nipro medical corporation, miami fl is initiating a nationwide recall of all glucopro insulin syringes (this does not include the glucopro syringe specific for use with the amigo insulin pump). these syringes may have needles that detach from the syringe. if the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in.
  • Action
    Each consignee will receive a Recall Notification Letter and response form by either fax or e-mail. Product should be returned to point of sale. Product not distributed should be collected and returned to Nipro Medical Warehouse in Memphis TN and Carolina Puerto Rico. Any questions or concerns can be addressed to the company at 787.769.2522.

Device

Device Recall NIPRO, GLUCOPRO INSULIN SYRINGES
  • Model / Serial
    A08022,  A08013,  A08017,  C08022,  C08013,  C08017,  B08013,  B08017.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (including Puerto Rico) Foreign Distribution: Canada, Barbados, Honduras, Jamaica, Panama, Trinidad and Tobago, and Costa Rica.
  • Product Description
    NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. || Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). || JD+01U3008-5C 1cc 30G x 5/16"; || JD+01U3013-5C 1cc 30G x 1/2"; || JD+01U3108-5C 1cc 31G x 5/16"; || JD+03U3008-5C .3CC 30 g X 5/16"; || JD+03U3013-5C .3CC 30 g X 1/2"; || JD+03U3108-5C .3cc 31G x 516"; || JD+05U3008-5C .5cc 30G x 5/16"; || JD+05U3013-5C .5cc 30G x 1/2"; || JD+05U3108-5C .5cc 31G x 5/16".
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • Manufacturer Address
    Nipro Medical Corporation, 3150 Nw 107th Ave, Miami FL 33172
  • Manufacturer Parent Company (2017)
    Nipro Corporation
  • Source
    USFDA