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05-01-2013, 09:59 PM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
- Blog Entries
Teleflex Medical is recalling Belly Bag Urine Collection Bag with Hip Belt
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 Id 64715
Product Type Devices
Recalling Firm Teleflex Medical
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.