Z-2248-2020Class II

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

Name: Z-2248-2020 safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Creator: Radiometer Medical ApS
Published: 2020-03-17
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2020-03-17 / Terminated / root cause: manufacturing process

FDA source

Radiometer Medical ApS began a recall of safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 on 2020-03-17. FDA classified it as Class II and gives the reason as "The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2248-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-17
Posted: 2020-06-03
Terminated: 2022-07-28
Recalling firm: Radiometer Medical ApS
Product: safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Product code: GIO Tube, Collection, Capillary Blood
Reason for recall: The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot numbers: R1431 - R1495

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2248-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2247-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2248-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2249-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code GIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)