Alaris Infusion Pump 8100 Bezel recall
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Why was Alaris Infusion Pump 8100 Bezel recalled?
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part 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?
Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392
- Product
- Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
- Recalling firm
- Tenacore LLC
- Quantity
- 1494
- Distribution
- US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
- Recall date
- April 14, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)