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Oridion CO2 sampling lines and water traps under the label recallZ-1333-2012 · Oridion Medical 1987 Ltd. · initiated Feb 16, 2012

Terminated All recalls posted in March 2012

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 Oridion Medical 1987 Ltd. 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

CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.

FDA root cause category: Packaging process control

What the company is doing

Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.

Recall details

Recall number
Z-1333-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 16, 2012
Posted by the FDA
Mar 29, 2012
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
2 million
Product code
CCK
FDA submissions
K012391, K012395, K013845, K042665, K980324, K980327
Distribution
Nationwide Distribution

Product description

Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2 Pediatric Part No. 010982; Smart SureBloc O2 Part No. 010983; Watertrap (package of 25 units) Part No. 010994; Sure VentLine Set Adult/Pediatric Part No.010986; Sure VentLine H Set Adult/Pediatric Part No.010987; Smart SureLine Guardian O2 Part No.012533; Smart SureLine Guardian O2 Long Part No.012534;

Code information (models, lots, serial numbers)

All lots

Other devices under the same FDA submission

6 devices cleared under K012391, K012395, K013845, K042665, K980324, K980327 — 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 61329).

Sources and updates

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