| Date Initiated by Firm | April 06, 2006 |
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| Date Posted | May 03, 2006 |
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| Recall Status1 |
Terminated 3 on August 12, 2009 |
| Recall Number | Z-0837-06 |
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| Recall Event ID |
35140 |
| 510(K)Number | K910492 |
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| Product Classification |
Tube, Gastro-Enterostomy - Product Code KGC
|
| Product | 20F Tri-Funnel Replacement Gastrostomy Tube |
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| Code Information |
Product Code 000720. Lot number: NGPL2270. |
Recalling Firm/
Manufacturer |
Bard Access Systems, Inc
5425 Amelia Earhart Dr
Salt Lake City UT 84116-3713
|
| For Additional Information Contact |
801-595-0700 |
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Manufacturer Reason
for Recall | Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection. |
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FDA Determined
Cause 2 | Error in labeling |
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| Action | Consignees were notified by letter on 04/06/2006. |
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| Quantity in Commerce | 110 units |
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| Distribution | Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = KGC
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