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Alaris EtCO2 Module Model 8300 - Product Usage: is intended… recallZ-2825-2020 · CareFusion 303, Inc. · initiated Jun 30, 2020

Class II Open, Classified All recalls posted in August 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDA root cause category: Device Design

What the company is doing

On 06/30/2020, Urgent Medical Device Recall Notifications will be mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical User: 1. If the end user observes a dim segment on the module, replace the module when feasible. There is no impact to the infusion. 2. Complete and return the Customer Response Card. Actions by Biomedical Engineering: If the module has a dim segment, please contactrecalling firm at 1-800-482-4822 to order a replacement display board (P/N TC10012952 for LVP Display Board, P/N TC10003525 for Syringe/PCA Display Board, P/N TC10008126 for EtCO2 Display Board, P/N TC10005026 for SpO2 Display Board) at no charge or send the module to the firm's Service Depot for repair. Actions by Recalling Firm: If the module has a dim segment as described in this notification, a replacement part will be provided at no charge. On 12/16/22, Medical Device Notifications were sent to customers informing them that they may have received impacted parts for repair purposes or (b) received product with impacted parts. Customers were provided with links to the original recall notices and asked to review the information and complete the customer response form.

Recall details

Recall number
Z-2825-2020
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 30, 2020
Posted by the FDA
Aug 19, 2020
Recalling firm
CareFusion 303, Inc.
Quantity
40671
Product code
FRN
FDA submissions
K133532
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, NJ, TN, NE, WA, KS, MI, MD, WV, KY, UT, MN, IA, GA, AL, DE, AK, VA, OK, NM, CT, SD, NV, ID, MT, ME, VT, MS, WY, NH, MP, DC, ND, GU, PR, AS, RI and the countries of TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, BH.

Product description

Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

Code information (models, lots, serial numbers)

All serial numbers

Other devices under the same FDA submission

4 devices cleared under K133532 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85919).

Sources and updates

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