Events

Recall of Latex Free* REF B1000P Belly Bag Urine Collection Bag with Sample Port1000 ml LOTSterile EO* Single use only, Manufactured and Distributed byRusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096Quantity 10****

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

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
31009
Event Risk Class
Class 3
Event Number
Z-0648-05
Event Initiated Date
2004-05-13
Event Date Posted
2005-03-23
Event Status
Terminated
Event Country
United States
Event Terminated Date
2009-08-31
Event Source
USFDA
Event Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36987
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

Collector, Urine, (And Accessories) For Indwelling Catheter - Product Code KNX
Reason
Firm received complaints of leaking urine collection bags.
Action
Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004.

Device

Latex Free* REF B1000P Belly Bag Urine Collection Bag with Sample Port*1000 ml LOT***Sterile ...

Model / Serial
Lots 121848, 122514, 124332, 125309 and 125885
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Australia, Japan and the UK
Product Description
Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****
Manufacturer
Teleflex Medical, Inc.

Manufacturer

Teleflex Medical, Inc.

Manufacturer Address
Teleflex Medical, Inc., 2450 Meadowbrook Pkwy, Duluth GA 30096-4635
Source
USFDA

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Recall of Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****