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Portex Low Dead Space Connector with Sideport, 3.5mm recallZ-1641-2014 · Smiths Medical ASD, Inc. · initiated Apr 10, 2014

Class I Terminated All recalls posted in June 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 Smiths Medical ASD, 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

One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

FDA root cause category: Packaging process control

What the company is doing

Smiths Medical sent an Urgent Medical Device Recall Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine all affected products and to complete the attached Response Form and return it to Smith Medical within 7 days of receipt of the notice. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at +1-800-258-5361.

Recall details

Recall number
Z-1641-2014
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Apr 10, 2014
Posted by the FDA
Jun 11, 2014
Recalling firm
Smiths Medical ASD, Inc.
Quantity
100 devices
Product code
BTR
FDA submissions
K790312
Distribution
US distribution in the state of North Carolina.

Product description

Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.

Code information (models, lots, serial numbers)

Lot or Serial No: 2553426

Other devices under the same FDA submission

28 devices cleared under K790312 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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