Recall Z-0066-2015 ยท DQY Catheter, Percutaneous
Arrow International Inc
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
| Date | Oct 14, 2014 (initiated Aug 6, 2014) |
| Status | Terminated |
| Reason | The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility. |
| Root cause | Packaging |
| Action | Arrow International sent an Urgent Medical Device Recall Notification letter, dated August 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product. Customers were instructed to remove the BD pre-filled saline syringe from the exterior of the packaging. To return the BD syringes, customers were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service. A customer servi |
| Quantity | 71255 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| 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 |
| K073451 | PRESSURE INJECTABLE PICC Arrow International, Inc., Jan 15, 2008 |
| K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc., Apr 21, 1978 |
| K810675 | ARROW RADIAL ARTERY CATHETERIZATION SET Arrow Intl., Inc., Mar 27, 1981 |
| K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP Arrow Intl., Inc., Aug 25, 1986 |