Device recall: Presource PBDS, Gyn Laparoscopy Kit, Circulator
FDA enforcement event 64736 is a device recall by Cardinal Health, Medical Products & Services of Park City, IL, initiated 26 Mar 2013 and classified Class I, with 14 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 6% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 12 Apr 2017. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Cardinal Health, Medical Products & Services.
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, Medical Products & Services, Park City, IL.
Reason for recall
"Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow."
Distribution
"Distributed in the states of AR, MS, SC, and TN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1193-2013 | Presource PBDS, Gyn Laparoscopy Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1194-2013 | A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1195-2013 | Presource PBDS, General Laparoscopy, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1196-2013 | Presource PBDS, Major Abdominal, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1197-2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1198-2013 | Presource PBDS, Extremity, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1199-2013 | Presource PBDS, Hand, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1200-2013 | Presource PBDS, Shoulder Arthroscopy, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1201-2013 | Presource PBDS, Shoulder Procedure, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1202-2013 | Presource PBDS, Total Hip, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1203-2013 | Presource PBDS, Total Joint, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1204-2013 | Presource PBDS, Total Knee, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1205-2013 | Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
| Z-1206-2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | 4,571 Kits total | Class I | Terminated | 15 May 2013 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in the states of AR, MS, SC, and TN."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Apr 2017. "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.