| Class 2 Device Recall Transpac IV Monitoring Kit | |
Date Initiated by Firm | September 27, 2016 |
Date Posted | November 15, 2016 |
Recall Status1 |
Terminated 3 on July 11, 2017 |
Recall Number | Z-0530-2017 |
Recall Event ID |
75491 |
510(K)Number | K061573 |
Product Classification |
Transducer, blood-pressure, extravascular - Product Code DRS
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Product | CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.-75 |
Code Information |
3274948 3281379 3293483 |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
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For Additional Information Contact | 949-366-2183 |
Manufacturer Reason for Recall | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
FDA Determined Cause 2 | Device Design |
Action | ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or potentially introduce small amounts of air into the line. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 2, or e-mail the following address: productreturns@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to recall@icumed.com. Customers with questions were instructed to call 866-829-9025. |
Quantity in Commerce | 105 units |
Distribution | Nationwide Distribution |
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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510(K) Database | 510(K)s with Product Code = DRS
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