Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm length, Item Numbers: 53126 and 55602.
FDA device recall Z-0642-04 · 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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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE (K962554) | Abbott Laboratories | 1997-11-07 |