Continental Medical Labs,Inc
Waterford, WI
Continental Medical Labs,Inc appears in FDA device records in Waterford, WI. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0894-2011 | Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Blood Center of Wisconsin, Milwaukee, WI. Port VAD Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. 3540CL, Manufactured for : McCormick Medical Distribution, Edmonds, WA 98020. The kits are used by blood centers to draw blood. | Continental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because Covidien reported that testing could not pick up an Over-Sulfated Chondroitin Sulfate (OSCS) contaminant in the purified heparin sodium USP. | Terminated | ||
| Z-1754-2010 | Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. | CML, Inc. was notified by A-M Systems in a letter dated March 31, 2010 that they were recalling a component of their Xenon Kit (ViroMax viral and bacterial filter) because the filters may have a leak at the seam where the two halves of the filter are bonded together. | Terminated | ||
| Z-0357-2007 | Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central. Manufactured in the USA for: CRS Medical Diagnostics, Inc., Pewaukee, WI. | Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain