Recall Z-2454-2021 ยท FPA Set, Administration, Intravascular
CAREFUSION
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
| Date | Aug 2, 2021 |
| Status | Open, Classified |
| Reason | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device. |
| Root cause | Process control |
| Action | On 08/02/21, Urgent Medical Device Correction notices were mailed and emailed to consignees who were asked to notify recalling firm if this issue was experienced at 1-844-823-5433, productcomplaints@bd.com . Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device. If during priming the clinician encounters an occluded needle-free connector, take the following actions: 1) Depress the syringe plunger while the syringe is still attached to the needle-free connector. 2) If unable to depress the plunger, pull back on the syri |
| Quantity | 1,463,647 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061285 | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS Cardinal Health, Alaris Products, Jul 26, 2006 |