Z-1257-2015Class II

Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap...

Name: Z-1257-2015 Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2015-01-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-01-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN... on 2015-01-22. FDA classified it as Class II and gives the reason as "Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary". 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-1257-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-22
Posted: 2015-03-06
Terminated: 2016-04-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311054 Legacy Part number: 478605
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthcare issued an Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on January 22, 2015 both in the United States and elsewhere for communication with affected customers. Siemens advises customers to use caution when applying the Capillary Caps with Siemens Multicap glass and Multicap-S plastic capillaries to minimize the potential for breakage or bending.
Quantity in commerce: 32384
Distribution: Worldwide Distribution. US Nationwide, Australia, Austria, Belgium, Bosnia, Herzegovina, Canada, Colombia, Croatia, Curacao, Czech Republic, Estonia, Finland, France, Georgia, Germany, Great Britain, Hong Kong, Ireland, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1257-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1256-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06
Z-1257-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06
Z-1258-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06

Product code JKA

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)