Recall Z-1830-2012 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
| Date | Jun 26, 2012 (initiated May 3, 2012) |
| Status | Terminated |
| Reason | Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status. |
| Root cause | Labeling mix-ups |
| Action | Arrow International sent an Urgent Field Corrective Action letter dated May 3, 2012 to their US consignee. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to quarantine any affected inventory and relay the information to their Arrow Sales Representative. The letter stated that the Arrow Sales Representative would affix new labels to each kit within their inventory. The consignee was instructed to sign the Acknowledgement Form provided by the Sales Representative which would then be submitted to Arrow. An Urgent Field Safety |
| Quantity | 634,912 |
| Distribution | Worldwide Distribution - United States (nationwide) include the state of Texas. and the countries of: ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900263 | ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc., Jul 24, 1990 |