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Terminated

Sterile, Drape, Headset, Lower, Part Number 888944-01.

FDA Recall Z-1707-2009 · Posted 2009-09-01

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeMMP
Date Initiated2008-08-15
Date Terminated2012-05-15
Product Quantity50 each

Reason for Recall

GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.

Firm Action

GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2002-04-17K993687UROVIEW 2800Ge Dec Medical Systems · 1999-12-21K970185STERILE DISPOSABLE EQUIPMENT MAGNET COVERContour Fabricators, Inc. · 1997-04-10K820692BANDBAG, WRAP, STERILEContour Fabricators, Inc. · 1982-05-03K782155GENERAL EQUIPMENT COVERContour Fabricators, Inc. · 1979-01-17

Official Source

View FDA Recall →

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

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