Recall Z-2825-2015 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
| Date | Sep 30, 2015 (initiated Aug 27, 2015) |
| Status | Terminated |
| Reason | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products. |
| Root cause | Process control |
| Action | An urgent recall notification letter, dated August 27, 2015, was sent to direct consignees to inform them of the issue and provided instructions for removing the syringes from the kit and returning product along with the response form. |
| Quantity | 73714 |
| Distribution | Nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001587 | 19 GA PLASTIC REINFORCED EPIDURAL CATHETER Arrow Intl., Inc., Jul 12, 2000 |
| K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc., Mar 21, 2001 |
| K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION Arrow Intl., Inc., Oct 27, 2000 |
| K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc., Oct 31, 2001 |
| K042126 | PICC Arrow Intl., Inc., Aug 27, 2004 |