FDA Medical Device Recalls (openFDA)
Radiometer Medical ApS: safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
- Recall number
- Z-2248-2020
- Recalling firm
- Radiometer Medical ApS
- Product
- safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
- Status
- Terminated
- Initiated
- 2020-03-17
- Posted
- not on file
- Terminated
- 2022-07-28
- Reason
- The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
- Root cause
- Process control
- Action
- The method of notification of the recall was a customer letter sent to all consignees via email and a hard copy sent via FedEx 2nd day with tracking and proof of delivery; date of issue was 3/17/20. Customers were instructed to do the following with the recalled product: -Cease using the Blood Samplers from the affected lots. -Check inventory of Blood Samplers from the affected lots. -Check for Blood Samplers from the affected lots distributed in the institution. -Collect any Blood Samplers from the affected lots. -Complete the Recall Response Form (last page of the customer advisory letter) and return it to the representative. -Discard the collected Blood Samplers of the affected lots. For any questions contact at 1-800-736-0600 option 1, Monday-Friday, 9am EST to 7pm EST.
- Quantity
- 269 units
- Distribution
- U.S.: AK, AL, AR, CA, CO, CT, FL,GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI. OUS: Australia (New Zealand), Austria, Brazil Canada, China, Czech Republic (Slovakia), Denmark, Dubai (United Arab Emirates), Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Italy, Japan, Kazakhstan, Lithuania, Malawi, Malaysia, Mauritius, Netherlands (Belgium), Nicaragua, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Turkey (Cyprus), and United Kingdom.
- Lot, serial or model codes
- Lot numbers: R1431 - R1495
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GIO
- Firm FEI
- 3002807968
- Firm city
- Bronshoj
- Firm state
- not on file
- Firm country
- Denmark
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