Device Recall Baxter, RAPIDFILL Syringe 의 리콜

Recall

72946

Class 2

Z-0731-2016

2015-12-21

2016-01-30

Terminated

United States

2016-08-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142564

All lots of rapidfill syringe strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

An Urgent Product Recall notification was sent to consignees via USPS, first class mail on 12/21/15. Baxter Healthcare has asked customers to do the following: l. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return, credit and alternative products. 3. Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. 4. Communicate the contents of the letter to your staff if affected products are distributed to other facilities or departments. 5. Conduct a consumer-level recall for dealers, wholesalers, distributors, resellers, or Original Equipment Manufacturers that distributed affected product to other facilities.