Recall Z-2663-2020 ยท PTI Non-Coring (Huber) Needle
Becton Dickinson & Company
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680)
| Date | Jul 20, 2020 (initiated Jun 19, 2020) |
| Status | Terminated |
| Reason | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection. |
| Root cause | Process control |
| Action | URGENT MEDICAL DEVICE RECALL notification letters dated 6/19/20 were sent to customers. PLEASE TAKE THE FOLLOWING ACTIONS: 1. Immediately review your inventory for the specific catalog and lot numbers referenced in Attachment A. Discontinue use of those devices and destroy all product subject to this recall following your institutions process for destruction. MDS-20-1979 Page 2 of 28 BD Medical 1 Becton Drive Franklin Lakes, NJ 07417 USA bd.com 2. Share this notification with all users of the product within your facility network to ensure they are also aware of this recall. 3. Complete the a |
| Quantity | 5,296,132 total |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set C.R. Bard, Inc., Aug 18, 2016 |