Recall Z-0185-2024— CareFusion 303, Inc.
Class I · Ongoing
Class I FDA medical device recall by CareFusion 303, Inc., initiated 2023-09-15. It names 4 FDA 510(k) clearances: K211218, K133532, K072105 and 1 more. Product: BD Alaris Syringe Module, REF 8110. Reason: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-09-15
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K211218 — BD Alaris System with Guardrails Suite MX v12.1.2
- K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MX
- K072105 — ALARIS SYSTEM WITH MMS, MODEL 8XXX
- K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD Alaris Syringe Module, REF 8110
Reason for recall
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.