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| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) [Fenwal, Inc.] | BioPortfolio

13:46 EST 27th January 2019 | BioPortfolio

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BLOOD-PACK™ Unit with an Integral SEPACELL™ FLEX-EXCEL™ Leukocyte Reduction Filter Using CPD/ADSOL™ Red Cell Preservation Solution for Whole Blood Collection and Filtration of Red Blood Cells

Rx only

Contains Sample Diversion System for the collection of whole blood samples for laboratory testing. Also includes 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.

Instructions for Use

Collection Procedure:

Use aseptic technique.

Notes:

Precautions:

Notes:

Precautions:

Precaution: Failure to break the in-line cannula completely may result in restricted blood flow.

Warning:

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 access device, be careful to avoid contact with any blood droplets on the Luer or sampling site. Discard used access device appropriately.

Precaution: Once the desired blood volume is collected, complete steps 20-24 within approximately 4 minutes to avoid possible clot formation in the tubing.

Precaution: The needle guard must be held stationary while the needle is withdrawn into it.

Note: Step 24 may be performed prior to step 23 if desired.

Component Preparation:

Notes:

Note: It is important to pack the filter properly in the centrifugation 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 26 through 32 provide one method for centrifuge cup loading.

Note: Do not place filter, breakaway cannula or check valve on lower half of the container. Check valve must be placed in a horizontal position (Figure 4a). Avoid the clear (red tip) side from pointing downward (Figure 4b).

Note: Steps 28-30 may be performed in the reverse order. The specific stacking order and methodology may also vary depending on the workstation setup and centrifuge equipment used.

Note: Ensure that the filter, breakaway cannula and check valve do not move to the lower portion of the centrifuge cup when loading. Failure to properly orient these components during centrifugation can result in damage.

Note: The tabs of the containers may be tucked inward to avoid the unit from interfering with free movement of the cup.

Filtration Procedure:

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

Store at Controlled Room Temperature.USP Definition of “Controlled Room Temperature”United States Pharmacopeia, General Notices.United States Pharmacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MD

Fenwal, Inc. Lake Zurich, IL 60047 USA

1-800-933-6925

Made in USA

07-19-07-274    REV: A     11/2012

– Manufacturer

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

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

DONORCARE is a trademark of ITL Corporation.

© 2012 Fenwal, Inc. All rights reserved.

Code 4R1583

10 Units

Fenwal™

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

Double For Collection and Processing of 500 mL Blood

Sample Diversion System, DONORCARE™ Needle Guard, 16 ga. Ultra Thin Wall Needle

Rx only

Each unit consists of a PL 146 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 146 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, non-pyrogenic fluid pathSee instructions for use.

Store at Controlled Room Temperature (refer to direction insert).

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

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

DONORCARE is a trademark of ITL Corporation.

Fenwal, Inc. Lake Zurich, IL 60047 USA

07-28-07-171 REV: A

Manufacturer

Fenwal, Inc.

Active Ingredients

Source

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