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Blood Administration Set

B. BRAUN MEDICAL INC. · Model V2400 · UDI-DI 04046964188596

BRZ Prescription
10
510(k) clearances
1,836
Adverse events (9 deaths)
24
Recalls
28
Facilities

Description

Gravity Blood Administration Set with No Injection Site

Recalls

DateFirmReason
2014-07-17Genesis BPS, LLC.Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
2014-07-17Genesis BPS, LLC.Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
2014-07-17Genesis BPS, LLC.Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
2013-04-01Hospira Inc.It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood
2013-04-01Hospira Inc.It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood
2013-04-01Hospira Inc.It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood
2013-04-01Hospira Inc.It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood
2013-04-01Hospira Inc.It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood
2013-04-01Hospira Inc.It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood
2013-04-01Hospira Inc.It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.