Device recall: Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
Cadence Inc. (Cranston, RI) initiated this device recall on 9 Jul 2015; FDA lists 2 product records under event 71674, 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 29 Jul 2016. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Cadence Inc..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cadence Inc., Cranston, RI.
Reason for recall
"Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel."
Distribution
"Nationwide Foreign Canada, Denmark. Italy"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2364-2015 | Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212 | 766 units | Class II | Terminated | 19 Aug 2015 |
| Z-2365-2015 | Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209 | 1665 units | Class II | Terminated | 19 Aug 2015 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel."
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 Canada, Denmark. Italy"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Jul 2016. "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.