Recall Z-0106-2021 ยท LJE Catheter, Nephrostomy
Cook Inc.
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.
| Date | Aug 31, 2020 |
| Status | Terminated |
| Reason | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation. |
| Root cause | No Marketing Application |
| Action | URGENT: MEDICAL DEVICE CORRECTION notification letters dated 8/31/20 were sent to customers. Actions to be Taken by the Customer 1. If affected products have already been placed within a patient, the indwell time should not exceed 4 weeks. If the current indwell time has exceeded 4 weeks, consider removing and/or replacing the product. 2. Understand that if an affected product is placed within a patient longer than 4 weeks, there is an increased potential for breakage, kinking, encrustation, migration, and/or infection to occur. 3. Please maintain a copy of this notice with the current IFU or |
| Quantity | 380 |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set Cook Incorporated, Mar 27, 2019 |