Tenacore LLC Recall 87470
Description: Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Tenacore LLC Recall 87470 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1332-2021 |
| Event ID | 87470 |
| Event Description | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 |
| Product Type | Devices |
| Distribution | US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA |
| Quantity | 1494 |
| Recall Reason | 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. |
| Device Classification | 20210414 |
| Device Code Info | 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 |
| Center Classification Date | 20210402 |
| Recall Initiation Date | 20210225 |
| Recalling Firm | Tenacore LLC |
| Initial Notification | Letter |
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