Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Reported: April 14, 2021 Initiated: February 25, 2021 #Z-1332-2021
Product Description
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Reason for Recall
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.
Details
- Recalling Firm
- Tenacore LLC
- Units Affected
- 1494
- Distribution
- US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
- Location
- Santa Ana, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410. Recalled by Tenacore LLC. Units affected: 1494.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Critical. Recall number: Z-1332-2021.
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