FDA Device recall Z-1760-2022
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
- FDA Device
- Class II
- ongoing
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class II recall of BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 by Carefusion, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1760-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-01 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY |
Product
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
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.
Identifiers
| code_info | UDI-DI: 10885403237782, Lots: 22019085 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1760-2022%22
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