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Terminated

Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use

FDA Recall Z-0035-2011 · Posted 2010-10-20

Recall StatusTerminated
Product CodeNGT
Date Initiated2010-09-02
Date Terminated2012-08-23
Product Quantity13,734,640

Reason for Recall

There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility

Firm Action

Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 2, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue using syringes from the listed lots and return the attached Customer Reply Form via fax (866) 688-3185 as confirmation that notification had been received and that proper arrangements can be made to have the product returned to the firm. The customers were also instructed to inform their customers, if they have resold products, of the recall and instruct them to return the form, and verify that they have returned all unused syringes from any of the listed lots . NOTE: The customers were informed that they may alternatively have the products destroyed and certified to Excelsior that they have done so. They must include a copy of the certificate of destruction with the attached Customer Reply Form via fax. - Excelsior issued a press release on October 14, 2010. The press release advised consumers of the recall and requested that use of the product be immediately discontinued and returned to the point of purchase. Should you have any questions regarding the recalled product, please contact Excelsior Medical Customer Service at (800) 487-4276 or if you prefer by fax (866) 688-3185. You may also contact us at [email protected].

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA and countries including Canada and Brazil.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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