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U.S. Department of Health and Human Services

Class 3 Device Recall McKesson MediPak Elastic Bandage, Premium, Sterile

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 Class 3 Device Recall McKesson MediPak Elastic Bandage, Premium, Sterilesee related information
Date Initiated by FirmDecember 02, 2004
Date PostedDecember 24, 2004
Recall Status1 Terminated 3 on September 21, 2005
Recall NumberZ-0368-05
Recall Event ID 30550
Product Classification Bandage, Elastic - Product Code FQM
ProductMcKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide
Code Information Product Numbers 16-1033-2-STR, 16-1033-3-STR, 16-1033-4-STR, 16-1033-6-STR; lot numbers 3001 through 40999
Recalling Firm/
Manufacturer		 Cypress Medical Products, Ltd.
1202 S. Rte 31
McHenry IL 60050
For Additional Information ContactMs. Kristine Ozyuk
815-385-0100
Manufacturer Reason
for Recall		The elastic bandages which are labeled sterile have a lack of assurance of sterility.
FDA Determined
Cause 2		Other
ActionCypress Medical recalled the elastic bandages fro McKesson Medical-Surgical on 12/1/04 by telephone call and letter. McKesson was requested to sub-recall the product from their customers, which they did by letter dated 12/2/04.
Quantity in Commerce17,964 units
DistributionNationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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