Cardinal Health Presource kits with recalled BD Alaris infusion sets: correction posted in FDA recall database
Published November 8, 2026 · Coverage November 1–7, 2026, Pacific · Medium priority
FDA's medical device recall database posted on November 2, 2026 a Cardinal Health correction (record Z-0217-2027) for Presource kits containing BD Alaris pump infusion sets that were themselves recalled for performance issues; the record lists 415,636 kits. Cardinal's September 24, 2026 notice asked consignees to discontinue use of the affected BD Alaris pump infusion sets as the enclosed Becton Dickinson notice describes and, where affected kits are found, to quarantine them, alert clinicians, and affix a warning label to each kit telling clinicians to remove and discard the recalled components. Those instructions belong to record Z-0217-2027. A separate FDA recall page for Presource kits, updated November 9, 2026 (after this edition's coverage week), says the FDA has identified the recall it describes as the most serious type. The FDA records reviewed for this entry do not show that page and database record Z-0217-2027 to be the same recall event, so the classification of Z-0217-2027 is not established here.
Background
Presource kits are Cardinal Health convenience kits packaged together to be used to facilitate a single surgical or medical procedure. FDA's separate Presource recall page reports BD's statement that some Alaris pump sets with restrictive components and designs perform worse than previously disclosed, and the page lists BD's U.S. customer letter dated August 19, 2026 and FDA's recall page for the underlying BD Alaris infusion set recall dated October 5, 2026 (the FDA MedWatch feed dates that recall page October 14, 2026).
Who this affects
Hospitals using Cardinal Health Presource procedure kits that contain BD Alaris pump infusion sets.
Why it matters
Kits in stock may contain BD Alaris pump infusion sets that were recalled for performance issues, so a clinician opening a kit could use a recalled component unless the kit is labeled and the component removed. Operational reading: supply chain and nursing find affected Presource kits, quarantine them, apply the warning labels, and have clinicians remove and discard the recalled infusion-set components, as the notice in record Z-0217-2027 directs. The use-instruction guidance on the separate FDA page is not shown to apply to this record. Inference: this compounds work already under way for the BD Alaris infusion-set recall.
Required actions
- None stated as a legal requirement.
Recommended action
- Identify affected kits in inventory, quarantine them, and label them so that clinicians remove and discard the recalled components, as the notice directs
- Confirm clinicians have the BD performance disclosures
Scope and timing
- Authority status
- Other (FDA recall database posting of a firm-initiated correction)
- Responsible owner
- Supply Chain; Nursing; Clinical Engineering
- Publication date
- 2026-11-02 (FDA recall database posting)
- Other dates
- Firm notice 2026-09-24 per the FDA recall database record (FDA's recall page says the letter went out on September 23); FDA recall page update 2026-11-09 (after this edition's coverage week); earlier FDA Early Alert on Presource kits dated 2026-10-20 in the FDA MedWatch feed
Not established
The FDA page Class I statement is dated after this edition's coverage week.
Sources
Complete edition and supplemental material
This article in the complete report →
Executive triage, source-coverage limitations, context and forward horizons remain in the complete report.
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