Recall Z-2248-2020
Radiometer Medical ApS · initiated March 17, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Codes / lots: Lot numbers: R1431 - R1495
Reason for recall
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2248-2020
- Initiated
- March 17, 2020
- Terminated
- July 28, 2022
- Product code
- GIO – Tube, Collection, Capillary Blood
- 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…
- Recalling firm
- Radiometer Medical ApS, Bronshoj
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2247-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | 03/17/2020Terminated |
| Z-2249-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | 03/17/2020Terminated |