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Pediatric Kit with 30mL Flush Device, Item No. 46099-10 recallZ-2821-2016 · ICU Medical, Inc. · initiated Aug 10, 2016

Class II Terminated All recalls posted in September 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

FDA root cause category: Process control

What the company is doing

An Urgent Medical Device Recall Notification letter dated 8/10/16 was sent to all their customers who purchased the Transpac IV with SafeSet reservoir kit and without SafeSet Reservoir, and with Transpac IV with marvelous valve without SafeSet reservoir. The letter informs the customers that ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The recall letter list the affected products and lot numbers. Customers are informed of the actions to be taken. Customers with questions are 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 8, or e-mail the following address: [email protected]. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to [email protected].

Recall details

Recall number
Z-2821-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 10, 2016
Posted by the FDA
Sep 15, 2016
Recalling firm
ICU Medical, Inc.
Quantity
20 units
Product code
DRS
FDA submissions
K061573, K932188
Distribution
US Nationwide Distribution

Product description

Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: 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 (models, lots, serial numbers)

lot number 3274952

Other devices under the same FDA submission

26 devices cleared under K061573, K932188 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 74966).

Sources and updates

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