Food, drugs, devices › Cardinal Health 200, LLC
Device recall: Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
FDA enforcement event 82927 is a device recall by Cardinal Health 200, LLC of Mansfield, MA, initiated 30 Apr 2019 and classified Class II, with 17 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 968 device enforcement events initiated in 2019 carry the same class.
Status: Completed. 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, Mansfield, MA.
Reason for recall
"Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product"
Distribution
"Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2036-2019 | Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2037-2019 | Monoject Standard Hypodermic Needle Item code: 8881200029 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2038-2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2039-2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2040-2019 | Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2041-2019 | Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2042-2019 | Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2043-2019 | Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2044-2019 | Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2045-2019 | Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2046-2019 | Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2047-2019 | Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2048-2019 | Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2049-2019 | Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2050-2019 | Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2051-2019 | Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363 | N/A | Class II | Completed | 31 Jul 2019 |
| Z-2052-2019 | Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389 | N/A | Class II | Completed | 31 Jul 2019 |
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: "Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product"
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 Foreign: AU, BE, CA, DK, FI, GB, IE, NL"
Is the recall still ongoing?
FDA lists the status as Completed. "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.