FDA Medical Device Recalls (openFDA)
Radiometer America Inc: 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.
- Recall number
- Z-1442-06
- 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.
- Status
- Terminated
- Initiated
- 2006-06-29
- Posted
- 2006-08-26
- Terminated
- 2012-02-24
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Capillary caps with the Lot #0605068 or Lot #0605069.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GIO
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28