Recall Z-0091-2023— B. Braun Medical, Inc.

Name: FDA recall Z-0091-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-15

Class II · Ongoing

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2022-09-15. It names 3 FDA 510(k) clearances: K083723, K954123, K942988. Product: Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.. Reason: The extension set has a high probability of 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-15
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K083723 — A6 LUER ACCESS DEVICEB.Braun Medical, Inc.·cleared 2009-06-05
K954123 — LOW PROFILE SAFSITE Y-SITEB.Braun Medical, Inc.·cleared 1995-11-21
K942988 — FILTERED EXTENSION SETSB. Braun of America, Inc.·cleared 1995-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.

Reason for recall

The extension set has a high probability of 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.