10.5 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.
This recall has been terminated (originally issued June 5, 2003).
- Company
- Datascope Corp.
- Recall Initiated
- March 21, 2003
- Posted
- June 5, 2003
- Terminated
- August 1, 2003
- Recall Number
- Z-0916-03
- Quantity
- 60 units
- Firm Location
- Fairfield, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
Distribution
Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.
Lot / Code Info
REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.
Root Cause
Other
Action Taken
Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.
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