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Recall

Class I — Becton Dickinson & Company

Recalling firmBecton Dickinson and Company
Registered facilityView this company's 36 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusTerminated
ReasonAn 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.
ProductAlaris 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.
Quantity17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19)
DistributionWorldwide 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…
Initiated2019-05-06
Classified2019-07-11
Terminated2021-07-19
Recall numberZ-1770-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Becton Dickinson & Company (Z-1770-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82752/

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