Recalls / —

—#25386

Product

0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case

FDA product code

FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K984590

Affected lot / code info

all lots within expiration date of the following pre-filled syringes: Code 2K0901: 2 mL in 3 mL syringe Code 2K0903: 3 mL in 6 mL syringe Code K0905: 5 mL in 12 mL syringe Code 2K0906: 10 mL in 12 mL syringe Code 2K6011: 2 mL in 3 mL syringe w/cannula Code 2K6012: 3 mL in 6 mL syringe w/ cannula Code 2K6013: 5 mL in 12 mL syringe w/cannula Code 2K6014: 10 mL in 12 mL syringe w/cannula

Why it was recalled

Sterility questioned

Root cause (FDA determination)

Other

Action the firm took

Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.

Recalling firm

Firm

Baxter Healthcare Corp. Rt

Address

120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern

Nationwide, Canada, Honduras, Indonesia, Israel

Timeline

Recall initiated

2002-12-12

Posted by FDA

2003-01-23

Terminated

2004-06-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25386. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.