Product Description Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.

Recall Number Z-1158-2013

Classification Class II

Codes: Over 400 codes are involved in this recall - Please see FDA Enforcement report for May 1, 2013 for specific codes

Product Distributed Qty 190,103

Reason For Recall Sterile packaging may be compromised.

Event Detail

Event Id 64715

Product Type Devices

Status Ongoing

Recalling Firm Teleflex Medical
City Durham
State NC

Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-28

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.