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U.S. Department of Health and Human Services

Class 2 Device Recall Piston syringe

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 Class 2 Device Recall Piston syringesee related information
Date Initiated by FirmMay 16, 2003
Date PostedJune 05, 2003
Recall Status1 Terminated 3 on July 21, 2003
Recall NumberZ-0912-03
Recall Event ID 26356
510(K)NumberK875196 
Product Classification Syringe, Piston - Product Code FMF
ProductInject 10 Coronary Control Syringe (CCS), 10ml
Code Information REF/CAT No.: CCX010, Lot No''s. A257336, A258248, A258893, A263340.
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
FDA Determined
Cause 2		Other
ActionOn 5/16/2003, all distributors and consignees were notified by letter.
Quantity in Commerce7257 units
DistributionNationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FMF
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