Food, drugs, devices › Cardinal Health 200, LLC
Device recall: Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific di
FDA enforcement event 77895 is a device recall by Cardinal Health 200, LLC of Waukegan, IL, initiated 1 Aug 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 18 Jun 2019. Initiation: voluntary: firm initiated. Cardinal Health 200, LLC has 59 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cardinal Health 200, LLC, Waukegan, IL.
Reason for recall
"The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection."
Distribution
"Worldwide Distribution - US (Nationwide) and Internationally to Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3107-2017 | Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures | 184,102 kits | Class II | Terminated | 13 Sep 2017 |
Context
Other enforcement events for Cardinal Health 200, LLC
All 59 events for Cardinal Health 200, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (Nationwide) and Internationally to Canada"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Jun 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.