Date Initiated by Firm | August 05, 2014 |
Date Posted | August 20, 2014 |
Recall Status1 |
Terminated 3 on February 26, 2015 |
Recall Number | Z-2295-2014 |
Recall Event ID |
68973 |
Product Classification |
Tourniquet, nonpneumatic - Product Code GAX
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Product | Port Access Kit with MicroClave Clear Connector, Item No. B79104
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. 2705203 |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
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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 | 400 units |
Distribution | Nationwide Distribution - USA including AL and MD. |
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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