Z-1442-06

SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary...

Name: Z-1442-06 SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary...
Creator: Radiometer America Inc
Published: 2006-06-29
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-06-29 / Terminated

FDA source

Radiometer America Inc began a recall of SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890... on 2006-06-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1442-06
Status: Terminated
Initiated: 2006-06-29
Posted: 2006-08-26
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
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.
Product code: GIO Tube, Collection, Capillary Blood
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 root cause: 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.
Product codes and lots: Capillary caps with the Lot #0605068 or Lot #0605069.

Product code GIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)