Events

Recall of Device Recall STERILE FIELD SALINE FLUSH

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

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
    50848
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2009
  • Event Initiated Date
    2009-01-13
  • Event Date Posted
    2009-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77486
  • 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
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code NGT
  • Reason
    Sterility issue: there is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.
  • Action
    An Urgent Medical Device Recall letter (dated January 13, 2009) was sent to consignees via certified mail, with return receipt requested. The letter provided the reason for the recall and instructions to discontinue use and return (or destroy) the recalled product. The letter also instructed customers to complete the enclosed Customer Reply Form and fax (866-360-6211) to Excelsior Medical Corporation. If the affected product is destroyed on site, fax a copy of the certificate of destruction with the completed Customer Reply Form. Arrangements will be made by Excelsior Medical Corporation for the return of recalled product. Please direct questions to Excelsior Medical Customer Service at 800-487-4276.

Device

Device Recall STERILE FIELD SALINE FLUSH
  • Model / Serial
    Product codes: E0100 20, 100 92-240 and 100 92-30: External Lot #/Expiration Date 01-003-DS 9/1/2008, 34-021-BB 10/1/2008, 46-060-9D 10/1/2008, 34-023-BB 10/1/2008, 08-024-DS 5/1/2009, 09-005-DS 7/1/2009, 58-012-9D 10/1/2009, 58-025-9D 10/1/2009, 58-042-9D 10/1/2009, 59-007-9D 11/1/2009, 11-013-DS 7/1/2009, 12-011-DS 7/1/2009, 60-015-9D 12/1/2009, 60-020-9D 12/1/2009, 62-024-9D 2/1/2010, 62-025-9D 2/1/2010, 63-032-9D 3/1/2010, 64-027-9D 4/1/2010, 65-008-9D 5/1/2010, 19-002-DS 4/1/2010, 19-015-DS 5/1/2010, 66-029-9D 6/1/2010, 20-008-DS 5/1/2010, 67-036-9D 7/1/2010, 69-021-9D 9/1/2010, 69-036-9D 9/1/2010, 70-018-9D 10/1/2010, 23-014-DS 8/1/2010 and 24-019-DS 8/1/2010.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Sterile Field Saline Flush; || 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. || Excelsior Medical, Neptune, NJ. || This product is used for the flushing of venous access devices and intravenous tubing.
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • Manufacturer Address
    Excelsior Medical Corp, 1933 Heck Ave, Neptune NJ 07753
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA