Fresenius Medical Care Holdings, Inc 4/6/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

Warning Letter

April 6, 2011

VIA United Parcel Service

Dr. Ulf M. Schneider
Chairman of the Management Board
Fresenius SE
61346 Bad Homburg v.d.H.
Germany

RE: America CombiSet True Flow SeriesTN Hemodialysis Blood Tubing Set With Priming Set and Transducer Protectors

Refer to GEN1100186 when replying to this letter

Dear Dr. Schneider:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Fresenius Medical Care North America CombiSet True Flow Series Hemodialysis Blood Tubing Set With Priming Set and Transducer Protectors, Part Numbers 03-2695-9 and 03-2795-7 (modified CombiSet) in the United States (U.S.). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

Fresenius Medical Care provided information to the FDA Seattle District Office, on December 9, 2010, pertaining to the recall of the modified CombiSet. Fresenius Medical Care provided additional information to the FDA Seattle District Office on January 11, 2011, in response to a request for additional information by the FDA. Based on the information provided on these two dates, we have determined that:

You implemented design changes to the CombiSet, including a change in a tubing segment from a "thick" wall (Inner Diameter 0.168", Outer Diameter 0.265" and hardness of 70D) to a "thin" wall (Inner Diameter 0.180", Outer Diameter 0.265" and hardness of 76 +/- 2 Durometer.

You distributed the modified Combiset in the United States.

You initiated a recall of the modified CombiSet on November 19, 2010, due to device failure related to the design change.

You claim that design validations did not raise any new issues or unexpected results surrounding product performance, safety and effectiveness.

You believe that the modified Combiset received clearance under K962081.

Review of our records indicates that, while a premarket notification (510(k)) for the Combilines Hemodialysis Blood Tubing Set was cleared November 1, 1996 (K962081), the modifications made to the CombiSet tubing hardness were not cleared under K962081. Further, while you claim that design validations did not raise any new issues or unexpected results surrounding product performance, safety, and effectiveness, the change in material hardness affected the device performance characteristics, demonstrated by the device failures and the November 19, 2010, recall of the modified CombiSet.

Our evaluation of this information reveals that the these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g).  These devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).  For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)] The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.  The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. 

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.  Please provide a translation of documentation not in English to facilitate our review.

Please direct your response to Paul F. Tilton at the Food and Drug Administration, 10903 New Hampshire Ave., WO66-3540, Silver Spring, MD 20993, facsimile at (301) 847-8137. We remind you that only written communications are considered official.

Finally, you should know that the violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. 

Sincerely yours,

/s/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

 

 

 

 

 

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