FDA Device recall Z-1770-2019
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 1…
- FDA Device
- Class I
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class I recall of Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 1… by Becton Dickinson And, citing an incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1770-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-05-06 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein.
Reason
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
Identifiers
| code_info | Lot Numbers UDI: 07613203021135- 18096166 18096167 18096235 18096236 18096294 18096295 18096301 19026173 UDI…Lot Numbers UDI: 07613203021135- 18096166 18096167 18096235 18096236 18096294 18096295 18096301 19026173 UDI: 07613203015806- 17087410 17087411 18096003 UDI: 07613203021159- 18096803 18096804 UDI: 10885403223204- 18095427 18095428 UDI: 10885403227981- 18096296 18096293 18096273 18096272 18096229 18096228 UDI: 10885403233999- 17087192 17087329 17087330 17087331 18036906 18036907 UDI: 07613203019088- 18116304 UDI: 07613203021234- 18096302 18096422 UDI: 07613203021197- 19025787 UDI: 10885403232305- 18096500 18096501 18096611 UDI: 10885403228001- 18015347 18076591 18076660 UDI: 07613203012713- 17087446 UDI: 07613203012638- 18095286 18095287 18095355 UDI: 07613203012638- 17087336 17087337 17087412 UDI: 10885403226090- 18096312 18096313 18096358 (updated 8/26/19) UDI: 10885403227950- 18096609 18096610 UDI: 07613203021012- 17077279 17077398 17113133 17113134 17118801 17118810 18015266 18015267 18015351 18015353 1801 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1770-2019%22
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