Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
This recall has been terminated (originally issued March 10, 2015).
- Company
- Arrow International Inc
- Recall Initiated
- November 8, 2013
- Posted
- March 10, 2015
- Terminated
- March 16, 2015
- Recall Number
- Z-1259-2015
- Quantity
- 166 units
- Firm Location
- Reading, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Distribution
Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
Lot / Code Info
Lot Number: KF1111796 Exp. Date: 11/30/2013
Root Cause
Process control
Action Taken
Arrow International Inc notified accounts by letter dated 11/8/13 describing the problem and requested users to immediately discontinue use and return product. A Recall Acknowledgement form was to be completed and returned.
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