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Terminated

Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

FDA Recall Z-0500-2007 · Posted 2007-02-15

Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2006-11-08
Date Terminated2007-11-27
Product Quantity49 cases ( 294 units)

Reason for Recall

Chest drainage tubing incorrectly assembled and may disconnect from patient during use

Firm Action

Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.

Root Cause

Other

Distribution Pattern

Nationwide, including CA, and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043140EXPRESS AND OASIS CHEST DRAINAtrium Medical Corp. · 2004-12-08

Official Source

View FDA Recall →

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

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