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U.S. Department of Health and Human Services

Class 2 Device Recall Capillary Caps for RAPIDLyte Multicap and MulticapS Blood Collection Capillaries

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  Class 2 Device Recall Capillary Caps for RAPIDLyte Multicap and MulticapS Blood Collection Capillaries see related information
Date Initiated by Firm January 22, 2015
Date Posted March 06, 2015
Recall Status1 Terminated 3 on April 13, 2016
Recall Number Z-1257-2015
Recall Event ID 70287
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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
Code Information All lot codes
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Drive
Norwood MA 02062
For Additional Information Contact
781-269-3000
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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