—#70286

Product

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.

FDA product code: LDF — Electrode, Pacemaker, Temporary
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K960479
Affected lot / code info: Part number: AI 07155-IK, Lot #RF8015920 (Distributed in Canada, Croatia, Dominican Republic, Honduras, New Zealand, Russia, South Africa and Venezuela).

Why it was recalled

The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 312 Commerce Pl, Asheboro, North Carolina 27203-0552

Distribution

Distribution pattern: U.S. South Africa, Venezuela

Timeline

Recall initiated: 2008-04-01
Posted by FDA: 2008-09-16
Terminated: 2009-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70286. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.