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U.S. Department of Health and Human Services

Class 2 Device Recall Datascope

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 Class 2 Device Recall Datascopesee related information
Date Initiated by FirmMarch 21, 2003
Date PostedJune 05, 2003
Recall Status1 Terminated 3 on August 01, 2003
Recall NumberZ-0916-03
Recall Event ID 25995
510(K)NumberK964987 
Product Classification System, Balloon, Intra-Aortic And Control - Product Code DSP
Product10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.
Code Information REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.
Recalling Firm/
Manufacturer		 Datascope Corp
15 Law Drive
Fairfield NJ 07004-3206
For Additional Information ContactWhitney Torning
973-244-6136
Manufacturer Reason
for Recall		10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
FDA Determined
Cause 2		Other
ActionRecall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.
Quantity in Commerce60 units
DistributionProduct was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.
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 = DSP
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