• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Transpac IV Monitoring Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Transpac IV Monitoring Kit see related information
Date Initiated by Firm September 27, 2016
Date Posted November 15, 2016
Recall Status1 Terminated 3 on July 11, 2017
Recall Number Z-0415-2017
Recall Event ID 75491
510(K)Number K061573  
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
Product TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05
The 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.
Code Information 3192360 3210327 3225634 3242228 3242233 3242235 3242236 3242237 3242245 3242247 3242248 3242249 3242255 3242260 3242262 3242263 3253912 3264057 3264059 3264062 3264063 3273065 3273070 3273071 3284136
Recalling Firm/
Manufacturer
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
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 60,560 units
Distribution Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = DRS and Original Applicant = HOSPIRA, INC.
-
-