Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, Lot number RF8015920, For Export Only, 5 Fr. (110
FDA device recall Z-1908-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LDF
- Distribution
- U.S. South Africa, Venezuela
- Date initiated
- 2008-04-01
- Date posted
- 2008-09-16
- Date terminated
- 2009-12-08
- Location
- Asheboro, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER (K960479) | Arrow Intl., Inc. | 1996-10-17 |