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Recall Observatory FDA recall evidence

Device product

Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601

Z-1256-2015

January 22, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 70287
Status
Terminated
Classification
Class II
Quantity
10741
Official record key
device-enforcement:Z-1256-2015

Official wording

Reason: Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary

Code information: All lot codes

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary