Food, drugs, devices › DeRoyal Industries Inc
Device recall: Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulde
DeRoyal Industries Inc (Powell, TN) initiated this device recall on 22 Jan 2018; FDA lists 1 product record under event 79052, 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 19 Aug 2020. Initiation: voluntary: firm initiated. DeRoyal Industries Inc has 46 enforcement events on this register, with a median of 1 product record 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
DeRoyal Industries Inc, Powell, TN.
Reason for recall
"DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve."
Distribution
"US Distribution to: NY"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0637-2018 | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy | 181 units | Class II | Terminated | 28 Feb 2018 |
Context
Other enforcement events for DeRoyal Industries Inc
All 46 events for DeRoyal Industries Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve."
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: "US Distribution to: NY"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Aug 2020. "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.