Recall Z-1355-2011 ยท DQX Wire, Guide, Catheter
Arrow International Inc
ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization kit
| Date | Feb 17, 2011 (initiated Oct 29, 2010) |
| Status | Terminated |
| Reason | Sterility may be compromised. |
| Root cause | Other |
| Action | Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product. If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935. If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization N |
| Quantity | 800 units |
| Distribution | Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Bel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810675 | ARROW RADIAL ARTERY CATHETERIZATION SET Arrow Intl., Inc., Mar 27, 1981 |