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Arterial Safeset Transpac IT w/3 ml Reservoir and Single… recallZ-2159-2014 · ICU Medical, Inc. · initiated Jul 18, 2014

Class II Terminated All recalls posted in August 2014

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 has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

FDA root cause category: Nonconforming Material/Component

What the company is doing

ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.

Recall details

Recall number
Z-2159-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 18, 2014
Posted by the FDA
Aug 7, 2014
Recalling firm
ICU Medical, Inc.
Quantity
1,560
Product code
DRS
FDA submissions
K061573
Distribution
Worldwide Distribution - USA including Oregon and Internationally to Australia.

Product description

Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Code information (models, lots, serial numbers)

Lot No. 2841944, 2841945, 2859326, 2865873, 2869445

Other devices under the same FDA submission

22 devices cleared under K061573 — 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 68971).

Sources and updates

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