Alaris Pump recall
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall…
Why was Alaris Pump recalled?
The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 pumps manufactured between April 2011 and June 2017, that have bezel mechanical assemblies manufactured with FR-110 plastic resin. And all pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.
- Product
- Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall…
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 607618
- Distribution
- Worldwide Distribution - U.S. Nationwide CA, TX, NC, AL, ID, TN, IN, MA, UT, HI, NH, PA, IL, OR, FL, MI, VA, AR, OH, GA, NY, MD, MN, NM, AZ, KY, WI, NE, MS, DC, MO, KS, SC, LA, MT, WA, NJ, CO, CT, OK, AK, AS, CU, DE, GU, IA, ME, MP, ND, NV, PR, SD, VT, WV, WY; OUS: AE, AU, BH, CA, CH, CN, GI, IL, IN, KW, MX, MY, NL, NZ, PH, PK, QA, SA, SG, TW, and ZA.
- Recall date
- July 24, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)