PlainRecordsFDA · Medical device recall
BD DTX Plus… and 8 more products
- Date posted by the FDA
- Sept. 21, 2005
- Status
- Terminated
- Filed by
- Becton Dickinson Medical Systems
- Reason
- Actuating tab may detach from the stopcock body, allowing fluid leak.
- Distribution pattern
- Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
9 products in this recall
BD DTX Plus…
- Product
- BD DTX Plus, 60'' complete single-line pressure monitoring kit.
- Quantity
- 5470 units
- Codes and lots
- Part Number 682000, Lot Numbers: 407104, 407387
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1557-05
BD DTX Plus…
- Product
- BD DTX Plus, 60'' complete dual-line pressure monitoring kit.
- Quantity
- 95 units
- Codes and lots
- Part Number 682007, Lot Number 407467
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1558-05
BD DTX Plus…
- Product
- BD DTX Plus, 72'' complete single-line pressure monitoring kit.
- Quantity
- 165 units
- Codes and lots
- Part number 682014, Lot number 407026.
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1559-05
BD DTX Plus…
- Product
- BD DTX Plus, Stand-alone pressure transducer with 3cc/hr flush device
- Quantity
- 290 units
- Codes and lots
- Part number 682018, Lot number 407109.
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1560-05
BD DTX Plus…
- Product
- BD DTX Plus, 12'' single-line neonatal pressure monitoring kit.
- Quantity
- 1060 units
- Codes and lots
- Part number 682040, Part numbers 407033, 408053.
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1561-05
BD DTX Plus…
- Product
- BD DTX Plus, Custom single-line neonatal pressure monitoring kit.
- Quantity
- 150 units
- Codes and lots
- Part number 687104, Lot Number 408038.
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1562-05
BD DTX Plus…
- Product
- BD DTX Plus, Custom single-line pressure monitoting kit.
- Quantity
- 85 units
- Codes and lots
- Part number 687196, Lot number 410174.
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1563-05
BD DTX Plus…
- Product
- BD DTX Plus, Custom triple-line pressure monitoring kit.
- Quantity
- 140 units
- Codes and lots
- Part number 687206, Lot numbers: 411062, 411539, 501148.
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1564-05
BD DTX Plus…
- Product
- BD DTX Plus, Custom dual-line pressure monitoring kit.
- Quantity
- 405 units
- Codes and lots
- Part number 687341, Lot Numbers: 410177, 411063, 411540.
- Recall started
- July 1, 2005
- Device type
- System, Measurement, Blood-Pressure, Non-Invasive
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by phone and fax on 07/01/2004.
- Recall number
- Z-1565-05
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1557-05, Z-1558-05, Z-1559-05, Z-1560-05, Z-1561-05, Z-1562-05, Z-1563-05, Z-1564-05 and others. The agency record governs; check it and the company before acting.