Recall Z-2247-2020 ยท GIO Tube, Collection, Capillary Blood
Radiometer Medical ApS
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
| Date | Mar 17, 2020 |
| Status | Terminated |
| 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 lette |
| Quantity | 1314 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, Fi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.