Radiometer Medical ApS Akandevej 21 Bronshoj Denmark safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AK, AR, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI