Recall Z-1158-2013— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2013-03-28, terminated 2014-05-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Sterile packaging may be compromised..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-28
- Terminated
- 2014-05-01
- Firm location
- Durham, NC, United States
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.
Reason for recall
Sterile packaging may be compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.