—#84753

Product

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

FDA product code: MMP — Cover, Barrier, Protective
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K021049, K782155, K820692, K970185, K993687
Affected lot / code info: all lots

Why it was recalled

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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2008-08-15
Posted by FDA: 2009-09-01
Terminated: 2012-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84753. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.