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U.S. Department of Health and Human Services

Class 2 Device Recall MicroClave

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  Class 2 Device Recall MicroClave see related information
Date Initiated by Firm August 05, 2014
Date Posted August 20, 2014
Recall Status1 Terminated 3 on February 26, 2015
Recall Number Z-2293-2014
Recall Event ID 68973
Product Classification Tourniquet, nonpneumatic - Product Code GAX
Product CAP Change Kit w/MicroClave Clear, Item No. B78109

BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Code Information Lot No. 2704633, 2705206
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact Robert Reese
801-264-1732
Manufacturer Reason
for Recall		 ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
FDA Determined
Cause 2		 Other
Action An Urgent recall letter dated 8/5/2014 was sent to all customers who purchased the BD PosiFlush SF Saline Flush Syringe 10ml. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM to 4:00PM PST at (866) 829-9025 and select option 8, or email customerservice@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or email to recall@icumed.com.
Quantity in Commerce 300 units
Distribution Nationwide Distribution - USA including AL and MD.
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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