| Class 2 Device Recall Capillary Caps for RAPIDLyte Multicap and MulticapS Blood Collection Capillaries | |
Date Initiated by Firm | January 22, 2015 |
Date Posted | March 06, 2015 |
Recall Status1 |
Terminated 3 on April 13, 2016 |
Recall Number | Z-1258-2015 |
Recall Event ID |
70287 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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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 |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics Inc 2 Edgewater Drive Norwood MA 02062
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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 | 6184 |
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 |
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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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