—#89807

Product

Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8502.

FDA product code: KPE — Container, I.V.
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot numbers: G075531, G076937, and G076794

Why it was recalled

Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Urgent Product Recall letters dated 2/15/10 were mailed on the same date via first class mail to the affected direct accounts to the attention of the Director of Pharmacy, the Director of Materials Management, and the Director of Risk Management. The accounts were informed of the potential for the pH of the products to exceed the upper specification limits for pH prior to the product expiration date. The accounts were requested discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia

Timeline

Recall initiated: 2010-02-15
Posted by FDA: 2010-04-29
Terminated: 2012-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.