Centurion Medical Products Premie Pack and Meconium Pack Recall

Recall Class:

Class I

Date Recall
Initiated:

September 22, 2009

Product:

Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115

Model

Lot/Serial Numbers

NOTE: These are the Portex uncuffed pediatric sized tracheal tubes which were subject to the Class I recall with Smiths Medical.

2.5 mm product code 100/105/025;
3.0 mm product code 100/105/030;

3.5 mm product code 100/105/035;
2.5 mm product code 100/111/025;
3.0 mm product code 100/111/030;
3.5 mm product code 100/111/035;
2.5 mm product code 100/126/025;
3.0 mm product code 100/126/030;
3.5 mm product code 100/126/035;
2.5 mm product code 100/141/025;
3.0 mm product code 100/141/030;

3.5 mm product code 100/141/035.

NOTE: These kits contain Portex uncuffed pediatric sized tracheal tubes which were subject to the Class I recall with Smiths Medical.

Premie Pack
901087
903267
907307
910297

901218
908258
2009020990
2009022390

Full Term Meconium Pack
01297
07097
09107

12037
06028
2008091501
2008120801
2009033001
2009062201

These products were distributed from January 1, 2007 through September 22, 2009.

Use:

A tracheal tube is inserted through the nose or mouth into a patient’s windpipe in order to ensure that the airway is not obstructed and that oxygen or anesthesia reaches the lungs. These tubes are used in both adults and pediatric patients, but not newborns or infants.

Recalling Firm:

Centurion Medical Products
301 Catrell Drive
Howell, Michigan 48843-1703

Reason for Recall:

The manufacturer of the pediatric tracheal tubes used in these kits recalled them because they were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient.

Public Contact:

The company may be contacted at 1-800-248-4058 (Eastern Time).

For more information, see Useful Link below.

FDA District:

Detroit

FDA Comments:

The company notified the sales representative about the recall on September 22, 2009 by email. The single customer was notified by letter which was dated September 23, 2009. The product was removed from the customer’s inventory on September 28, 2009 and returned to the recalling firm.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Link: