CARESITE SMALLBORE EXT SET T-PORT 5 IN — Class II medical device recall Z-0092-2023

Ongoing recall by B. Braun Medical, Inc., reported 2022-10-26, distributed nationwide. The extension set has a high probability of potential failure which could lead to possible leakage or detachme

Recall number	`Z-0092-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	B. Braun Medical, Inc., Allentown, PA, United States
Recall initiated	2022-09-15
Classified	2022-10-14
Reported by FDA	2022-10-26
Distributed	Nationwide (US)
Countries outside the US	CA, SA
Reason classes	packaging, device malfunction
UPC / GTIN / UDI-DI	`04046964298691`
Lot numbers	`61762215`, `61762791`, `61767369`, `61779625`, `61791895`, `61806047`

Product

CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.

Reason for recall

The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0092-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.