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U.S. Department of Health and Human Services

Class 3 Device Recall Cruciform Slit Valve

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 Class 3 Device Recall Cruciform Slit Valvesee related information
Date Initiated by FirmJanuary 06, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 03, 2004
Recall NumberZ-0585-04
Recall Event ID 28392
510(K)NumberK790126 K853363 
Product Classification Shunt, Central Nervous System And Components - Product Code JXG
ProductCruciform Slit Valve
Code Information UbaV/V020/07-2003
FEI Number 2518608
Recalling Firm/
Manufacturer		 Phoenix Biomedical
2495 General Armistead Ave
Norristown PA 19403
For Additional Information ContactCourtney Smith
610-539-9300
Manufacturer Reason
for Recall		mislabeled - product actually Single Valve
FDA Determined
Cause 2		Other
ActionThe recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.
Quantity in Commerce5 units
DistributionThe product was shipped to two hospitals - one in CA and one in AZ.
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 = JXG
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