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U.S. Department of Health and Human Services

Class 2 Device Recall Replacement Gastrostomy Device

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 Class 2 Device Recall Replacement Gastrostomy Devicesee related information
Date Initiated by FirmSeptember 23, 2008
Date PostedDecember 12, 2008
Recall Status1 Terminated 3 on November 08, 2011
Recall NumberZ-0420-2009
Recall Event ID 49523
510(K)NumberK013144 
Product Classification Gastrointestinal Tube (and accessories) - Product Code KNT
ProductDual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
Code Information 43APA035, 43ARA005, 43BOA039, 43BQA008, 43BQA046, 43COA017, 43COA039, 43CQA017, 43CQA236, 43DOA014, 43DPA208, 43DPA209, 43DQA011, 43EOA017, 43EOA045, 43EPA017, 43EPA044, 43EPA210, 43FOA080, 43FOA111, 43FQA002, 43GPA174R, 43GPA175R, 43GPA192R, 43GQA003, 43HOA034, 43HPA021R, 43HPA053R, 43HQA004, 43INA014, 43IOA041, 43IPA021R, 43IPA043R, 43IQA004, 43JNA004, 43JNAO47, 43JNA206, 43JOA018, 43JPA017, 43JPA038, 43JQA003, 43KNA015, 43KOA017, 43KPA016, 43KPA056, 43KQA003, 43KQA030, 43LNA055, 43LOA027, 43LPA009, 43LPA039, 43LQA005, 43LQA032, HURB3524, HURB4420, HURD1921, HURG1448, HURH1084, HURJ0602, HURK1510, HURB2428, HURD0505, HURE2896, and HURJ0601. 
FEI Number 3006260740
Recalling Firm/
Manufacturer		 C R Bard Inc
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		Gastrostomy device anti-reflux valve may allow leakage from the stomach.
FDA Determined
Cause 2		Component design/selection
ActionCustomers notified by letter (Product Field Action letter) on September 23, 2008 and instructed to remove and return any affected product to Bard Access Systems, Inc (BAS). Customers were instructed in the recall letter to respond by completing and faxing the enclosed Reply Form and Inventory Reconciliation Form. For assistance, contact BAS customer service at 800-290-1689.
Quantity in Commerce1212 units
DistributionWorldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = KNT
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