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Caresite recallZ-0624-2026 · B Braun Medical Inc · initiated Oct 29, 2025

Open, Classified

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 B Braun Medical 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

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

FDA root cause category: Process control

What the company is doing

B Braun notified consignees on about 10/29/2025 via letter. Consignees were instructed to follow "Interim Measures for Users" as outlined in the letter for secondary infusions via gravity sets and if using secondary infusions with infusion pumps. Consignees were also instructed to inform all users and post the applicable attachment(s) in care areas where secondary infusions may be administered and where IV administration sets and pump administration sets may be stored until further notice. B. Braun will provide additional notification when users may resume their normal secondary administration process without the need for the modified workflow. Consider priming all IV administration sets and pump administration sets with normal saline or other standard solutions prior to priming with expensive medications to avoid loss of expensive medications or occupational exposure to hazardous medications in the event the set is unable to be primed. If difficulty priming is encountered, obtain a replacement device and file a customer complaint with B. Braun. Additionally, consignees were requested to ensure all pertinent employees and customers are informed, post the notification where affected products are stored, and complete and return the "Urgent Medical Device Correction Acknowledgement Form."

Recall details

Recall number
Z-0624-2026
Status
Open, Classified
Initiated by the company
Oct 29, 2025
Posted by the FDA
Nov 26, 2025
Recalling firm
B Braun Medical Inc
Quantity
12,225,913 units
Product code
FPA
FDA submissions
K083723, K790062
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Product description

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

Code information (models, lots, serial numbers)

1. Catalog Number: 354204; Primary UDI-DI: 04046964182075; Unit of Dose UDI-DI: 04046964182068. 2. Catalog Number: 354205; Primary UDI-DI: 04046964182099; Unit of Dose UDI-DI: 04046964182082. 3. Catalog Number: 354206; Primary UDI-DI: 04046964182112; Unit of Dose UDI-DI: 04046964182105.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97816).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page