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| CPD/ADSOL Red Cell Preservation Solution System (PL 2209) [Fenwal, Inc.] | BioPortfolio

12:25 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx only

Contains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DonorCare Needle Guard.

Integral filter unit intended for leukocyte reduction of AS-1 Red Blood Cells:

The leukocyte reduced Red Blood Cells may then be stored for the maximum allowable dating period.

This Product Contains Dry Natural Rubber.

Instructions for Use

Collection Procedure:

Use aseptic technique.

Note: Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.

Note: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures.

Precautions:

Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected.

Precaution: Complete steps 13 - 22 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.

Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer.

Notes:

Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately.

Precaution: The needle guard must be held stationary while the needle is withdrawn into it.

Note: Step 22 may be performed prior to step 21 if desired.

Component Preparation: Notes:

Note: It is important to pack the filter properly in the centrifuge cup to avoid damage to the filter during centrifugation. Do not place the filter, breakaway cannula or check valve in the lower half of the centrifuge cup.

Note: Steps 24 through 30 provide one method for centrifuge cup loading.

Filtration Procedure:

Precaution: Red blood cell products collected from certain donors may have extended filtration times and the potential for ineffective filtration and leukoreduction.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Made in USA

07-19-55-442

Iss. January 2008

FENWAL, BLOOD-PACK, TRANSFER PACK, ADSOL, and FLEX-EXCEL are trademarks of Fenwal, Inc.

Baxter is a registered trademark of Baxter International, Inc.

Sepacell is a registered trademark of Asahi Kasei Medical Co., Ltd.

DonorCare is a trademark of ITL Corporation.

Rx only

This Product Contains Dry Natural Rubber.

The Blood-Pack unit with Integral Filter is manufactured with two different sets of segment numbers as shown below. The use of two sets of numbers requires special processing in order to assure component traceability. The following process is one suggested method which may be implemented in the blood processing lab but not at the collection site.

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Made in USA

07-19-44-337Iss. August 2004

Baxter, Blood-Pack, Transfer Pack and Adsol are trademarks of Baxter International Inc.

Code 4R1586

10 Units

Baxter

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack™ Unit; Transfer Pack™ Container with Adsol™ Red Cell Preservation Solution; Integral Sepacell Flex-Excel™ Red Cell Leukocyte Reduction Filter

Triple For the Collection and Processing of 500 mL Blood

Y-Sampling Site, DonorCare Needle Guard, 16 ga. Ultra Thin Wall Needle

Each unit consists of a PL 2209 Plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 2209 Plastic Satellite Container with 110 mL of Adsol Red Cell Preservation Solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 2209 Plastic Transfer Pack Container; one Integral Sepacell Flex-Excel Red Cell Leukocyte Reduction Filter and one empty 450 mL PL 2209 Plastic Transfer Pack Container for the storage of AS-1 Red Blood Cells, Leukocytes Reduced.

Sterile, nonpyrogenic fluid path

See instructions for use.

Store at room temperature.

Rx only

U.S. Pat. Nos.: 5,314,421; 5,372,143; 5,507,525; 5,055,609; 6,132,413; 6,367,634; 6,422,397; 6,688,476; 6,745,902; pat. pend.

FENWAL, BLOOD-PACK, ADSOL, PL 2209, TRANSFER PACK and FLEX-EXCEL are trademarks of Fenwal, Inc.

Baxter is a trademark of Baxter International Inc.

Sepacell is a trademark of Asahi Kasei Medical Co., Ltd.

DonorCare is a trademark of ITL Corporation.

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Made in USA

07-28-55-566    01/2008

Manufacturer

Fenwal, Inc.

Active Ingredients

Source

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