Recall Z-1908-2008 ยท LDF Electrode, Pacemaker, Temporary
Arrow International Inc
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.
| Date | Sep 16, 2008 (initiated Apr 1, 2008) |
| Status | Terminated |
| Reason | The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly. |
| Root cause | Process control |
| Action | 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. |
| Distribution | U.S. South Africa, Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER Arrow Intl., Inc., Oct 17, 1996 |