Recall Z-1122-2019— Becton Dickinson & Company

Name: FDA recall Z-1122-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-07

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-03-07, terminated 2020-05-12. It names one FDA 510(k) clearance: K972404. Product: BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010. Reason: The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Terminated: 2020-05-12
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K972404 — VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)Bd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1997-07-22

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

BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

Reason for recall

The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.

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