ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International, Inc.. Drug facts, warnings, and ingredients follow.
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 whole blood up to 72 hours after blood collection. The leukocyte reduced blood products may then be stored for the maximum allowable dating period.
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:
a. Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.
b. Remove needle cover, being careful not to drag the cover across the needle point.
Note: In difficult collection conditions (e.g. slow blood flow), leave the needle guard disengaged, behind the hub during collection. Engage the needle guard at the end of blood collection.
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Precaution: The needle guard must be held stationary while the needle is withdrawn into it.
·
a. Place folded sterile gauze over puncture site and hold in place with finger tip without exerting pressure.
b. Hold sides of needle guard near the front, between the index finger and thumb. Pull the tubing smoothly until the needle is locked into the needle guard.
c. Confirm the needle lock by:
1. Listen for the 2nd “click” as the needle is drawn into the needle guard.
2. Ensure the tubing cannot be pulled through the needle guard.
Note: Step 22 may be performed prior to step 21 if desired.
Filtration Procedure:
Precaution: Whole blood collected from certain donors may have extended filtration times and the potential for ineffective filtration and leukoreduction.
Note: The time of whole blood filtration may vary depending on processing option selected.
a. Within 8 hours of collection if whole blood is held at ambient temperature.
b. Within 72 hours of collection if whole blood is refrigerated.
c. Mix unfiltered whole blood thoroughly. Invert the primary container and hang the filter set such that the filter remains vertical. To achieve maximum flow rate, allow set to hang to full length.
Note: The storage container must remain below the level of the filter during filtration.
Note: Manual or mechanical pressure should not be used to increase the flow rate through the filter.
Note: Tubing below the filter should not be stripped at any time during the filtration process.
Note: If the filtration of whole blood is initiated at ambient temperature and not completed within 8 hours after blood collection, then filtration should be completed between 1 and 6°C.
Note: If a QC sample is desired, thoroughly mix the filtered whole blood and strip the donor segment tubing. Use the last segment (or segments) as the QC sample.
Component Preparation Procedure:
Note: Platelet concentrates are not intended to be made with this product.
a. Within 8 hours of blood collection if whole blood is held at ambient temperature.
b. Within 3 days of blood collection if whole blood is refrigerated.
Note: Fresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18°C or colder within 8 hours after blood collection.
Warning: Failure to achieve closed system processing conditions negates the extended storage claim and the red cell product must be transfused within 24 hours.
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
Made in USA
1-800-933-6925
07-19-07-537 REV: A
11/2012
FENWAL, BLOOD-PACK, TRANSFER PACK and ADSOL 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 4R3339
10 Units
Fenwal™
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit; TRANSFER-PACK™ Container with ADSOL™ Red Cell Preservation Solution; Integral SEPACELL™ Whole Blood Leukocyte Reduction Filter
Triple For the Collection and Processing of 450 mL Blood
Y-Sampling Site, DONORCARETM Needle Guard, 16 ga. Ultra Thin Wall Needle
Rx only
Each unit consists of a PL 146 Plastic primary container with 63 mL of CPD solution containing 1.66 g Sodium Citrate (dihydrate) USP, 1.61 g Dextrose (monohydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 146 Plastic TRANSFER-PACK container with 100 mL of ADSOL Red Cell Preservation Solution containing 2.2 g Dextrose (monohydrate) USP, 900 mg Sodium Chloride USP, 750 mg Mannitol USP, 27 mg Adenine USP; one empty 400 mL PL 146 Plastic TRANSFER-PACK container; one integral SEPACELL Whole Blood Leukocyte Reduction Filter and one empty 450 mL PL 146 Plastic TRANSFER-PACK container for the storage of AS-1 red blood cells, leukocytes reduced.
Sterile, non-pyrogenic fluid path
See instructions for use.
Store at Controlled Room Temperature (refer to direction insert).
FENWAL, BLOOD-PACK, ADSOL, and TRANSFER-PACK 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
Made in USA
07-28-05-526 REV: A
ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)
anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit |
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Labeler - Fenwal, Inc. (794519020) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Fenwal International, Inc. | 091164590 | MANUFACTURE(0942-6466) |