Severity
Critical
FDA Devices recall · Reported August 21, 2019
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…
Medline Industries Inc recalled Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Ce… - a critical-severity action.
Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Ce… was recalled by Medline Industries Inc in August 21, 2019. Reason: This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue wi…. Check the official notice for the remedy. Verify recall #Z-2067-2019 with the FDA Devices before acting.
The recall
Medline Industries Inc issued this critical-severity FDA Devices recall-This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue wi….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2067-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2067-2019) was formally reported on August 21, 2019, with the manufacturer initiating the action on May 10, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Medline Industries Inc is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 4890.
The documented reason for this recall is: 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 o… Distribution data in the federal record shows the product reached: One distributor located in Illinois.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
4890
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2067-2019 |
| Date reported | August 21, 2019 |
| Date initiated | May 10, 2019 |
| Recalling firm | Medline Industries Inc |
| Firm location | Northfield, IL |
| Affected scope | 4890 |
| Distribution | One distributor located in Illinois. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
· 2026-07-02
· 2026-06-25
· 2026-06-18
GE Medical Systems Information Technologies Inc · 2026-06-03
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.