Home › Device types › GCB
Needle, Catheter
FDA product code GCB · Class 1 · General, Plastic Surgery
157
Registered devices
394
Adverse events
8
Recalls
8
510(k) clearances
Devices with this code
M-Drain Centesis Catheter — Mermaid Medical A/SACCEL® — B. BRAUN MEDICAL INC.PILLING — TELEFLEX INCORPORATEDRing-McLean — COOK INCORPORATEDMAK-NV™ — Merit Medical Systems, Inc.Jet-Vac Procedure Trays — PFM MEDICAL INCORPORATEDMAK-NV™ — Merit Medical Systems, Inc.Cook — COOK INCORPORATEDAccess Needle — Mermaid Medical A/SAccuStick™ Needle — BOSTON SCIENTIFIC CORPORATIONRing — COOK INCORPORATEDACCEL™ — B BRAUN INTERVENTIONAL SYSTEMS, INCCook — COOK INCORPORATEDJet-Vac Procedure Trays — PFM MEDICAL INCORPORATEDACCEL® — B. BRAUN MEDICAL INC.ACCEL® — B. BRAUN MEDICAL INC.Access Needle — Mermaid Medical A/SACCEL® — B. BRAUN MEDICAL INC.Cook — COOK INCORPORATEDCook — COOK INCORPORATEDMAK-NV™ — Merit Medical Systems, Inc.MAK-NV™ — Merit Medical Systems, Inc.ACCEL® — B. BRAUN MEDICAL INC.Cook — COOK INCORPORATED
Recent 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 |
| 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 l |
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