Food, drugs, devices › Cardinal Health 200, LLC
Device recall: Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
FDA enforcement event 90955 is a device recall by Cardinal Health 200, LLC of Waukegan, IL, initiated 28 Sep 2022 and classified Class II, with 8 product records.
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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. 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
"Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates ."
Distribution
"nationwide and Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0185-2023 | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | 1915308 units | Class II | Ongoing | 16 Nov 2022 |
| Z-0186-2023 | Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 | 409738 units | Class II | Ongoing | 16 Nov 2022 |
| Z-0187-2023 | Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 | 567475 units | Class II | Ongoing | 16 Nov 2022 |
| Z-0188-2023 | Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 | 1209260 units | Class II | Ongoing | 16 Nov 2022 |
| Z-0189-2023 | Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A | 499997 units | Class II | Ongoing | 16 Nov 2022 |
| Z-0190-2023 | Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A | 649213 units | Class II | Ongoing | 16 Nov 2022 |
| Z-0191-2023 | Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 | 414194 units | Class II | Ongoing | 16 Nov 2022 |
| Z-0192-2023 | Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A | 129412 units | Class II | Ongoing | 16 Nov 2022 |
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: "Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates ."
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 and Canada"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.