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Terminated

32CM DECATHLON STD KIT Models: DE27SH32 and DE27SH32-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis.

FDA Recall Z-0290-2010 · Posted 2009-11-17

Recalling FirmSpire Biomedical, Inc.
Recall StatusTerminated
Product CodeMSD
Date Initiated2009-10-23
Date Terminated2010-06-09
Product Quantity3981 units

Reason for Recall

There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira

Firm Action

Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - Nationwide, Government. Foreign: Canada, France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K06344115.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55Spire Biomedical, Inc. · 2007-02-12K06343115.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40Spire Biomedical, Inc. · 2007-01-29K06015515.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPSSpire Biomedical, Inc. · 2006-05-09K04285855CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPSSpire Biomedical, Inc. · 2004-12-03K040509ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40Spire Biomedical, Inc. · 2004-04-19K032061DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NHSpire Biomedical, Inc. · 2003-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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