Recall Z-1946-2020 ยท PND Midline Catheter
Becton Dickinson & Company
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
| Date | Mar 17, 2020 |
| Status | Terminated |
| Reason | Iincorrectly packaged without the required lidocaine as labeled |
| Root cause | Packaging change control |
| Action | BD issued Urgent Medical Device Recall letter issued on March 17, 2020 via Fed'x or email states reason for recall, health risk and action to take: 1.Examine your inventory of PowerGlide ST" Midline Catheter Maximal Barrier for product code ST018101D, Lot No. REDW0476. Inventory of this kit lot may be used by the clinician through alternate sourcing of lidocaine prior to initiating the procedure. Alternatively, any remaining inventory may be discarded. BD will provide you with a replacement for each kit discarded. 2.Share this recall notification with all users of the product within your |
| Quantity | 655 kits |
| Distribution | AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX), |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170158 | PowerGlide ST Midline Catheter C.R. Bard, Inc., Jun 1, 2017 |