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FENWAL, INC. · Model 4C2223 · UDI-DI 00811137010691
BRZ
Prescription
1
510(k) clearances
1,846
Adverse events (9 deaths)
24
Recalls
28
Facilities
Description
Blood Component Infusion Set- Standard Blood Component Filter Female Luer. Sterile Fluid Path
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-07-17 | Genesis BPS, LLC. | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. |
| 2014-07-17 | Genesis BPS, LLC. | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. |
| 2014-07-17 | Genesis BPS, LLC. | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. |
| 2013-04-01 | Hospira 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 |
| 2013-04-01 | Hospira 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 |
| 2013-04-01 | Hospira 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 |
| 2013-04-01 | Hospira 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 |
| 2013-04-01 | Hospira 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 |
| 2013-04-01 | Hospira 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 |
| 2013-04-01 | Hospira 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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Get your free API keyRead the docsData 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.