BD Alaris Syringe Module, REF 8110
Reported: November 15, 2023 Initiated: September 15, 2023 #Z-0185-2024
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.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 133,727 units
- Distribution
- Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; OUS (foreign): Canada, Germany, Cuba, Italy, Japan, South Korea, Turkey, United Arab Emirates, Australia, Bahrain, Botswana, Kuwait, Mexico, Netherlands, Philippines, Pakistan, Qatar, South Africa, Singapore, Belgium, Israel, India, New Zealand, Malaysia, Taiwan, Switzerland
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
BD Alaris Syringe Module, REF 8110. Recalled by CareFusion 303, Inc.. Units affected: 133,727 units.
Why was this product recalled? ▼
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Critical. Recall number: Z-0185-2024.
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