Terminated

safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1

FDA Recall Z-2248-2020 · Posted None

Recalling FirmRadiometer Medical ApS

Recall StatusTerminated

Product CodeGIO

Date Initiated2020-03-17

Date Terminated2022-07-28

Product Quantity269 units

Reason for Recall

The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.