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, 2477-000
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling certain Alaris Pump Infusion Sets due to a manufacturing defect involving incomplete wall thickness in the pumping segment. This defect can cause unintended medication delivery when the pump is not running, or faster-than-expected drug delivery when the pump is actively infusing. The recall affects approximately 183.5 million units across 17,992 lots, distributed nationwide in the United States, U.S. territories, and multiple countries including Canada, Australia, Mexico, and others.
The affected infusion sets are identified by specific model codes and lot numbers listed in the recall record. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution; US (nationwide distribution) to following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, ID, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico; and countries of: Australia, Belgium, Canada, Chile, Malaysia, Mexico, Panama, Singapore and Taiwa Quantity: 17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19) Lot/code info: 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 18015458 18015459 18015568 18026598 18026601 18036759 18036760 18036761 18036941 18036965 18036966 18036967 18037062 18037063 18037064 18075677 18075700 18075709 18075714 18075715 18075716 18076779 18076784 18076830 18086266 18086339 18093065 18093066 18093070 UDI: 07613203021012- 18093076 18093077 18095339 18095354 18095359 18095360 18095412 18095889 18095980 18095991 18095996 18096179 18096180 18115088 18115135 18116622 18116623 18116624 18116707 19013154 19013155 19023000 19026122 19026123 19026211 19033033 UDI: 07613203012430- 17077358 17113141 17113142 17113146 18023014
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.