Recall Z-1287-2018 ยท DYB Introducer, Catheter
Arrow International Inc
Arterial Access Tray, introducer catheter; Model: GU-04020
| Date | Oct 26, 2017 |
| Status | Terminated |
| Reason | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. |
| Root cause | Nonconforming Material/Component |
| Action | Teleflex/Arrow sent a letter dated October 26th, 2017. Customers are instructed to discontinue use and quarantine any products with the affected product codes and lot numbers. There is a Recall Acknowledgment Form that is requested to be completed that will allow the return and replacement of the affected product. Consignees without affected product on hand are also asked to return the form. |
| Quantity | 1190 |
| Distribution | US nationwide distribution, including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc., Apr 21, 1978 |