Tenacore LLC: Medical Device Recall in 2021 - (Recall #: Z-1332-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.
Product Description:

Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

Product Classification:

Class I

Date Initiated: February 25, 2021
Date Posted: April 14, 2021
Recall Number: Z-1332-2021
Event ID: 87470
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.

Status: Terminated
Product Quantity: 1494
Code Information:

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

Distribution Pattern:

US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA

Voluntary or Mandated:

Voluntary: Firm initiated