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Class I Medical Device Recall: Excelsior Medical Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL sy

Posted Oct 25 2010 9:00pm

Recall Class: Class I

Date Recall Initiated: September 2, 2010

Product: Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe)

This recall pertains ONLY to the 5mL fill in 6mL prefilled saline flush syringe with Normal Saline (0.9% Sodium Chloride), with the following product code numbers:

  • E0100-50
  • 10056-1000
  • 10056-240
  • 14056-240
  • 910056-1000
  • S5

The product code number can be found in the barcode on each syringe as well as on the carton label.

These devices were distributed from August 8, 2008 through August 10, 2010.

Use: The Excelsior Disposable 5mL fill in 6mL prefilled saline flush syringes are intended for the flushing of venous access devices (such as, inserted central catheters) and intravenous (IV) lines.

Recalling Firm:
Excelsior Medical Corporation
1933 Heck Avenue
Neptune, New Jersey 07753

Reason for Recall: There is a potential for leaking and loss of sterility. The device failure may result in an infection in the bloodstream which may result in serious injury or death.

Public Contact:

CONSUMERS and CUSTOMERS may contact the company, Monday through Friday, from 8AM through 8PM Eastern Time at 1-800-487-4276, by FAX at 1-866-688-3185 or by e-mail at recall10@excelsiormedical.com

FDA District: New Jersey

FDA Comments:

CONSUMERS: STOP using these syringes and return them to the place of purchase.

On September 2, 2010, the company sent an “Urgent Medical Device Recall” letter to all its customers and distributors. The letter described the product, problem, and the action to be taken by the customers. Included with the letter was a Customer Reply Form.

Excelsior Medical is arranging for the return or destruction and reimbursement of any products that are returned as a result of this recall.

Customers and distributors were instructed to STOP using or distributing syringes from the listed lots above and return the Customer Reply Form by FAX at 1-866- 688-3185 to confirm that the letter was received and that proper arrangements were made to have the product returned to the firm.

The customers were also instructed to inform their customers if they have resold these products. These other customers were informed about the recall and instructed to complete and return the form, and verify that they have returned all unused syringes from any of the above listed lots.

Excelsior Medical’s customers were informed that they may alternatively destroy the products and certify to Excelsior Medical that they have done so. They must include a copy of the certificate of destruction with the attached Customer Reply Form by FAX.

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 adverse health consequences or death.

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

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