Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, Lot number RF8015920, For Export Only, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use, Sterilized. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Arrow International Inc
- Recall Initiated
- April 1, 2008
- Posted
- September 16, 2008
- Terminated
- December 8, 2009
- Recall Number
- Z-1908-2008
- Firm Location
- Asheboro, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
Distribution
U.S. South Africa, Venezuela
Lot / Code Info
Part number: AI 07155-IK, Lot #RF8015920 (Distributed in Canada, Croatia, Dominican Republic, Honduras, New Zealand, Russia, South Africa and Venezuela).
Root Cause
Process control
Action Taken
Consignees were notified by letter on/about 04/11/ 2008. They were instructed to cease use and distribution, and quarantine all affected product. They were also instructed to complete an enclosed Acknowledgement & Stock Status Form and fax back to Arrow International. Consignees were further advised to communicate the recall notice to anyone who has received the affected product by providing a copy of the recall notice to their customer(s). Contact Arrow International, Customer Relations Department at 800-523-8446 if you have questions.