Recall Z-1770-2019 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications,
| Date | Jul 11, 2019 (initiated May 6, 2019) |
| Status | Terminated |
| Reason | An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, BD, sent "Urgent Medical Device Recall" letters dated 5/6/19 to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review your inventory for the specific model codes and lot numbers listed in the Affected Product Table. Destroy all product subject to the recall based on the affected product table -following your institutions process for destruction. 2. BD is instructing customers to discard all model codes and lot numbers with an expiration date between and including 05/2019 and 08/2020 |
| Quantity | 17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19) |
| Distribution | Worldwide Distribution; US (nationwide distribution) to following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, ID, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894842 | IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM Imed Corp., Sep 12, 1989 |