May 7, 1999

PRODUCT:	Seraflo Q-Set Hemodialysis Blood Tubing Set with IV Administration Set and Transducer Protectors
CATALOG NUMBERS:	205-Q01, 205-Q02, 205-Q03, 205-Q04, 205-Q05, 205-Q06, 205-Q07, 205-Q08, 205-Q09, 205-Q10, 205-Q11, 205-Q013, 205-Q14
LOT NUMBERS:	All lot numbers

Dear Hemodialysis Director/Risk Manager:

In our ongoing efforts to minimize potential risk to patient safety, we are writing to inform you of recent occurrences involving blood contamination of certain dialysis machines during hemodialysis treatment. Althin has received some reports of Transducer Protectors (TP) becoming wetted when the blood level in the arterial drip chamber rises. To date four (4) facilities have reported that blood has been found inside dialysis machines beyond the external TP luer connector. The manufacturer, Nissho Nipro Corporation Limited (NNC), is investigating these reports.

NNC believes that the prudent course of action is to recall all of these Blood Tubing Sets until they have further studied the reported events. It is believed that the likelihood of contamination of the dialysis machine and the potential for patient injury due to cross contamination is low.

Our records indicate that you received one or more of the above catalog numbers of Seraflo Q-Set Hemodialysis Blood Tubing Set with IV Administration Set and Transducer Protectors(s), distributed by Althin Medical Inc.

Nissho Nipro Corporation has recommended that you discontinue use of these blood tubing sets immediatley. Please contact Amaury Sanchez or Linda Hendricks at (305) 823-5240, extension 579 or 562 for product return instructions.

NNC has instructed Althin that until suitable replacement products are obtained, we should direct the users as follows:

• Inspect all dialysis equipment now to look for any evidence of blood or other contamination in the internal tubing or TP of the machine.
• When connection tubing connections to the dialysis equipment, tighten all connections to prevent air and/or blood leakage.
• Closely monitor the blood levels in all tubing. If there is an indication that blood may wet the TP in the line, adjust the drip chamber levels to prevent occurrence.
• If it is observed that a TP has been wetted, it should be replaced immediately with a new sterile TP using aseptic technique. In this event, it is extremely important that the wetted TP be thoroughly examined by the user to determine if any blood can be seen on the machine side of the TP. If evidence of strikethrough is seen, the event should be reported to the immediate supervisor or in accordance with facility protocols. The hemodialysis equipment should not be used on another patient again until the equipment has been thoroughly examined for any internal evidence of blood. Check the equipment to assure proper performance and disinfect it before future use.
• If it is observed that a TP has been wetted and there is no evidence of strikethrough on the machine side of the TP, no action is necessary. TP's were designed to prevent blood transmission and if there has been no strikethrough the TP has functioned as intended. However, the wetted TP still needs to be replaced with a new sterile TP to maintain proper pressures in the tubing circuit to assure accurate monitoring.
• As blood flow rates are adjusted, closely monitor arterial and venous drip chamber levels to ensure they are at the proper set points.

Although we believe that the potential for cross contamination is remote, if you see evidence that machine contamination may have occurred, handle according to manufacturers' directions and any internal protocols for your user facility.

This letter is being sent out with the knowledge of the US Food and Drug Administration (FDA). Centers may be contacted by the FDA to verify that these letters have been received and recommended actions have been implemented.

Please complete the attached form acknowledging your receipt of this letter and that you have taken appropriate actions. This form should be returned via FAX to Susan de la Vega (305) 825-5322

We apologize for any inconvenience this may cause you. If you need further assistance, please contact Thomas Kelly, Marketing Director, Althin Medical, Inc. at (800) 800-9951, extension 767 (Monday through Friday, 8:30 am to 5:00pm EDT).

Sincerely,

Susan de la Vega
Director, Quality Assurance &
Regulatory Affairs