Recall StatusTerminated
Date Initiated2015-12-21
Date Terminated2016-08-18
Product Quantity4,695
Reason for Recall
All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
Firm Action
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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
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.