Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.5 cm length, Item Numbers: 54152 and 55634.
FDA device recall Z-0658-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ross Products Division Abbott Laboratories
- Reason for recall
- The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.
- Action taken
- The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNT
- Distribution
- Nationwide; Australia, New Zealand, Italy.
- Date initiated
- 2004-03-01
- Date posted
- 2004-07-20
- Date terminated
- 2008-10-24
- Location
- Columbus, OH
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