On February 24th, 2021, Tenacore LLC initiated a nationwide recall of 2001 Tenacore
replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with
weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as
other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts
may result in free flow, over infusion, under infusion or interruption of infusion.
There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can
be found using the following link:

Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly
Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA

Consumers who have:

• Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or
timestamp 6 should stop the distribution and use of these and return them to Tenacore
LLC.
• Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between
July 2020 and Feb 2020, should be inspected per the instructions described below to
ensure that your device is not impacted. If it is, please return your device to Tenacore
LLC.

Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July
2020 through Feb 2021.

The following products have been recalled:

Name of Product UDI Model(s) Serial Number(s) Quantity
Bezel for repair of
CareFusion Alaris 8100
(TIPA-8100-4410)
N/A N/A Timestamp 5 and
Timestamp 6
1511
Pre-owned Alaris 8100 units
purchased from Tenacore
N/A N/A Please contact us
for the serial
number list
388
Alaris 8100 units repaired
by Tenacore
N/A N/A Please contact us
for the serial
number list
102

 

Product(s) can be identified by:

If you purchased parts from Tenacore:

1. Look at the rear side of the bezel.
2. Find the timestamp as shown in the picture below.
3. If the timestamp shows a 5 or 6, please follow the instructions in the notice for returning
these impacted parts to Tenacore.

If your Alaris 8100 device was repaired by Tenacore or you purchased it from Tenacore:

1. Looking from the top down for the ejector pin marks shown in the image below.
2. If NO ejector pin marks are identified, this module requires replacement of the bezel

 

 

Tenacore LLC voluntarily recalled the bezel part for repair of CareFusion Alaris 8100 after
becoming aware of possible cracking and separation of the bezel post, as shown
below. Tenacore LLC has notified the FDA of this action.

A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue)
as well as other damage to the bezel (e.g., external cracking). The separation of one or more
bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.

Tenacore LLC is notifying its distributors and customers by phone call, email, and physical
mail; and is arranging for return of all recalled product in order to replace or credit where
applicable.

(A) Back side of bezel assembly highlighting the bezel posts. (B) Side view of bezel post with NO separation. (C) Side view of bezel post WITH separation. (D) Top view of bezel post with NO separation. (E) Side view of bezel post WITH separation.

 

 

 

 

 

 

 

 

 

 

 

 

Tenacore LLC distributed the bezel nationwide.

Consumers with questions may contact the company via telephone at provide 1-800-297-
2241 between the hours of 8:00 AM and 4:00 PM (Pacific Time). Consumers may also contact
the company via e-mail at quality@tenacore.com.

Adverse reactions or quality problems experienced with the use of this product may be
reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular
mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and return to the address on
the pre-addressed form, or submit by fax to 1-800-FDA-0178

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