Drug recall
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general…
FDA recall event 69319 · Class II · DeRoyal Industries Inc
Key facts
| Event ID | 69319 |
|---|---|
| Recall numbers | Z-0097-2015, Z-0098-2015 |
| Recalling firm | DeRoyal Industries Inc |
| Product type | Devices |
| Products | DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital, Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. |
| Initiation date | Aug 22, 2014 |
| Report date | Oct 29, 2014 |
| Termination date | Apr 15, 2015 |
| City | Powell |
| State | TN |
| Country | United States |
| FEI number | 1043214 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: