Food, drugs, devices › Carefusion 2200 Inc
Device recall: Manometer, 550 ml three-Way Stopcock; STERILE;
Carefusion 2200 Inc (Vernon Hills, IL) initiated this device recall on 23 Feb 2017; FDA lists 6 product records under event 76620, classified Class II.
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 9 Jul 2019. Initiation: voluntary: firm initiated. Carefusion 2200 Inc has 16 enforcement events on this register, with a median of 2 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
Carefusion 2200 Inc, Vernon Hills, IL.
Reason for recall
"The integrity of the sterile packaging is potentially compromised."
Distribution
"Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1421-2018 | Manometer, 550 ml three-Way Stopcock; STERILE; | 4,240 units | Class II | Terminated | 25 Apr 2018 |
| Z-1422-2018 | JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE; | 790 units | Class II | Terminated | 25 Apr 2018 |
| Z-1423-2018 | ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE; | a.) 13,010 units b.) 2116 units | Class II | Terminated | 25 Apr 2018 |
| Z-1424-2018 | JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE; | — | Class II | Terminated | 25 Apr 2018 |
| Z-1425-2018 | JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE; | 14,200 units | Class II | Terminated | 25 Apr 2018 |
| Z-1426-2018 | Thoracentesis/ Paracentesis Kit 10/CS; STERILE; | 1200 units | Class II | Terminated | 25 Apr 2018 |
Context
Other enforcement events for Carefusion 2200 Inc
All 16 events for Carefusion 2200 Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The integrity of the sterile packaging is potentially compromised."
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: "Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Jul 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.