Drug recall
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2)…
FDA recall event 80021 · Class II · Galt Medical Corporation
Key facts
| Event ID | 80021 |
|---|---|
| Recall numbers | Z-2558-2018, Z-2559-2018, Z-2560-2018, Z-2561-2018, Z-2562-2018, Z-2563-2018, Z-2564-2018, Z-2565-2018 |
| Recalling firm | Galt Medical Corporation |
| Product type | Devices |
| Products | 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05…, 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #…, 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b)…, 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b)…, Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, and 3 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate… |
| Initiation date | May 2, 2018 |
| Report date | Aug 8, 2018 |
| Termination date | Jul 20, 2020 |
| City | Garland |
| State | TX |
| Country | United States |
| FEI number | 3000718472 |
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
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: