Retiro De Equipo (Recall) de Device Recall Baxter RenAmin (Amino Acid) Injection

Recall

55016

Class 2

Z-1528-2010

2010-02-15

2010-04-29

Terminated

United States

2012-01-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89806

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. baxter decided to remove all potentially affected products even though there have been no out-of-specification ph results at the 0, 6 and 12 month intervals. the recall was initiated on 2/15/10.

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.