FDAClass INovember 15, 2023

BD Alaris Syringe Module recall: Labeling Error

BD Alaris Syringe Module, REF 8110

Why was BD Alaris Syringe Module recalled?

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots/ UDI-DI:10885403516047, 10885403515323, 10885403811043, 10885403515255 10885403811036, 10885403515262, 10885403811012, 10885403515279, 10885403424267

Product
BD Alaris Syringe Module, REF 8110
Recalling firm
CareFusion 303, Inc.
Quantity
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
Recall date
November 15, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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