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Terminated

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

FDA Recall Z-1122-2019 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2019-03-07
Date Terminated2020-05-12
Product Quantity6,509,600

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.

Firm Action

Urgent Medical Device Recall notification letters dated 3/7/19 were distributed to customers.

Root Cause

Process change control

Distribution Pattern

US distribution to the states of FL and NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972404VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997-07-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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