Recall Z-1351-2011 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia 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 | 14,030 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
| K770356 | ANESTHESIA KIT, EPIDURAL, SINGLE SHOT Arrow Intl., Inc., Mar 1, 1977 |