Recall Z-1756-2022 ยท FPA Set, Administration, Intravascular
CAREFUSION
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
| Date | Sep 13, 2022 (initiated Aug 1, 2022) |
| Status | Open, Classified |
| Reason | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker. |
| Root cause | Error in labeling |
| Action | On 8/1/22 Correction-recall notices were emailed or mailed to customers and distributors who were asked to do the following: 1) Destroy affected devices following your institutions process for destruction. 2) Share this notification with all users within your facility network to ensure all are aware. The correction-recall notice should also be shared with any organization where the potentially affected product has been transferred. 3) Complete and return the response form. In addition distributors were informed that the recalling firm plans to notify all affected customers directly so they w |
| Quantity | 19,925 |
| Distribution | US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET Medegen Medical Manufacturing Services, Jun 22, 2005 |