• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SafeClinitubes capillary caps (purple)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
 Class 2 Recall
SafeClinitubes capillary caps (purple)
see related information
Date Posted August 26, 2006
Recall Status1 Open
Recall Number Z-1442-06
Recall Event ID 36007
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/
Radiometer America Inc
810 Sharon Dr
Westlake, Ohio 44145-1598
For Additional Information Contact Vince Sigmund
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.
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.

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55