Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.

FDA Recall Z-1540-2009 · Posted 2009-06-18

Recall StatusTerminated
Product CodeCHL
Date Initiated2009-02-23
Date Terminated2009-07-29
Product Quantity1048 boxes of 25 cartridges each.

Reason for Recall

Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

Firm Action

Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.

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.

↑