Recall Z-1944-2024 ยท FPA Set, Administration, Intravascular
BD SWITZERLAND SARL
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
| Date | May 31, 2024 (initiated Apr 18, 2024) |
| Status | Open, Classified |
| Reason | Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates. |
| Root cause | Process control |
| Action | On 04/18/2024, the firm sent an URGENT: MEDICAL DEVICE PRODUCT RECALL" Letter via FedEx Express Saver to customer informing them that BD has received customer reports of the Alaris" Pump Infusion Set Low Sorbing Tubing (PE Lined) drip chamber becoming detached from the tubing for the catalog number and lot number referenced above. BD has confirmed that this issue is isolated to catalog number, 10013072 only and a single lot (no. 22115368) where mis-assembly of the drip chamber to the tubing occurred. Customers are instructed to: 1. Ensure the contents of this Product Recall communication are |
| Quantity | 11.300 sets |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS Alaris Medical Systems, Inc., Aug 6, 2002 |