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Terminated

Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush

FDA Recall Z-0926-2017 · Posted 2017-01-03

Recalling FirmNurse Assist, Inc
Recall StatusTerminated
Product CodeNGT
Date Initiated2016-10-04
Date Terminated2017-08-16
Product Quantity386,175 syringes

Reason for Recall

Potential contamination with B. cepacia.

Firm Action

Nurse Assist, Inc. sent an Urgent Medical Device Recall letter dated October 4, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use, a Returned Goods Authorization would be provided for return of the affected product. If product was further distributed consignees were instructed to make every effort to retrieve any of the unused product. For questions consignees should call 800-649-6800 or email [email protected]. For questions regarding this recall call 817-231-1300.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.

Official Source

View FDA Recall →

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

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