Recall Z-1613-2022 ยท LKF Cannula, Manipulator/Injector, Uterine
Mckesson Medical-Surgical Inc. Corporate Office
Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
| Date | Aug 26, 2022 (initiated May 25, 2022) |
| Status | Open, Classified |
| Reason | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
| Root cause | Environmental control |
| Action | Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to pr |
| Quantity | a. 30 each b. 0.3 cs |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) Ackrad Laboratories, Aug 8, 1996 |