Class I — Medline Industries Inc
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment which directly impacts amount of occlusion force necessary to fully seal the tube. This defect prevents the pump from complete occlusion and results in the potential for over-infusion of drug product into the patient. |
| Product | Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or intermittently deliver fluids, medications, blood and blood products to adult, pediatric or neonatal patients. |
| Quantity | 4890 |
| Distribution | One distributor located in Illinois. |
| Initiated | 2019-05-10 |
| Classified | 2019-08-12 |
| Terminated | 2021-08-18 |
| Recall number | Z-2067-2019 |
| Initiation | Voluntary: 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 — Medline Industries Inc (Z-2067-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82951/
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