Alaris Pump Infusion Set — Class I medical device recall Z-1770-2019
Terminated recall by Becton Dickinson & Company, reported 2019-07-17, distributed nationwide. An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affec
| Recall number | Z-1770-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2019-05-06 |
| Classified | 2019-07-11 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2021-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CL, MX, MY, PA, SG, TW |
| Reason classes | device malfunction |
| Lot numbers | 07613203011310, 07613203012430, 07613203012638, 07613203012713, 07613203015806, 07613203019088, 07613203019149, 07613203019460, 07613203020992, 07613203021012, 07613203021098, 07613203021135, 07613203021159, 07613203021197, 07613203021234, 10885403223204, 10885403226090, 10885403227950, 10885403227974, 10885403227981, 10885403227998, 10885403228001, 10885403228018, 10885403232305, 10885403233999, 10885403235122, 17077013, 17077131, 17077267, 17077268, 17077279, 17077313, 17077358, 17077398, 17087192, 17087193, 17087329, 17087330, 17087331, 17087334 and 219 more |
| Model numbers | 10010453, 10010454, 10012144, 10013361T, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 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 and 2 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1770-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.