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Kellett
COOK INCORPORATED · Model G20155 · UDI-DI 00827002201552
GCB
Prescription
8
510(k) clearances
394
Adverse events (5 deaths)
8
Recalls
76
Facilities
Description
Kellett Translucent Drainage Access Catheter with Echotip Needle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-01 | Cook Incorporated | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| 2020-04-26 | Argon Medical Devices, Inc | Tungsten coils of the guidewire included in the introducer kit were detaching. |
| 2020-03-26 | Becton Dickinson & Company | The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. |
| 2014-11-05 | Custom Healthcare Systems, Inc. | An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The N |
| 2014-10-20 | Pfm Medical Inc | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| 2014-10-20 | Pfm Medical Inc | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| 2014-10-20 | Pfm Medical Inc | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| 2013-08-28 | Carefusion 2200 Inc | Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potentia |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.