—#133256

Product

Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10328655 Legacy Part number: 478527

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: All lot codes

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Drive, Norwood, Massachusetts 02062

Distribution

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.

Timeline

Recall initiated: 2015-01-22
Posted by FDA: 2015-03-06
Terminated: 2016-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.