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U.S. Department of Health and Human Services

Class 2 Device Recall SafeClinitubes capillary caps (purple)

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  Class 2 Device Recall SafeClinitubes capillary caps (purple) see related information
Date Initiated by Firm June 29, 2006
Date Posted August 26, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1442-06
Recall Event ID 36007
Product Classification Capilliary Caps - Product Code GIO
Product SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787.
Code Information Capillary caps with the Lot #0605068 or Lot #0605069.
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
800-736-0600
Manufacturer Reason
for Recall		 Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak.
FDA Determined
Cause 2		 Other
Action The firm sent a recall letter to their customers on 6/29/2006. The letter identifies the problem and kit numbers and lot numbers for the affected kits, and as well as the Lot Numbers for the defective 905-787, capillary caps subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected lot numbered products; 2) Identify and discard any of the recalled bags contained in the kits or ordered separately; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm''s Technical Support Department should the customer have any questions concerning the recall letter.
Quantity in Commerce 886 units
Distribution Nationwide distribution --- including states of IL, NJ, NE, MO, PA, NY, WI, MN, UT, WA, OK, FL, MI, TX, CA, IN, OH, MO, OR, AK, MA, MS, VA, NH, NM, AR, TN, WI, ID, CT, SD, ME, NC, GA, NC , LA, CO, UT, NC, MD, AL, ND, FL, IA, AZ, SC, KY, KS, and NV.
Total Product Life Cycle TPLC 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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