Sterile, Drape, Headset, Upper, Part Number 888945-01.

FDA device recall Z-1708-2009 · posted 2009-09-01 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

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.

Action taken

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

Status

Terminated

Product code

MMP

Quantity affected

50 each

Distribution

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

Date initiated

2008-08-15

Date posted

2009-09-01

Date terminated

2012-05-15

Location

Waukesha, WI

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