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Russel Pneumofix-8 (US)

SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Model PDF119 · UDI-DI 05060483570402

GCB Prescription

510(k) clearances

394

Adverse events (5 deaths)

Recalls

Facilities

Description

The Russell PneumoFix®-8 is a sterile decompression needle composed of a veress-tipped needle inserted through an 8cm catheter, with a low-pressure release valve. The veress tip and indicator device assist with the safe insertion with a minimal risk of injuring the underlying lung, whilst the low-pressure release valve permits the release of tension pneumothorax with minimal potential of subsequent air re-entry. The Russell PneumoFix®-8 is composed of a stainless steel veress-tipped needle with a Tecoflex Polyurethane catheter. The catheter contains barium sulphate (20%) which enables the catheter to be visible during X-ray.

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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Data 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.