FDA Medical Device Recalls (openFDA)
Baxter Corporation Englewood: Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
- Recall number
- Z-0731-2016
- Recalling firm
- Baxter Corporation Englewood
- Product
- Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
- Status
- Terminated
- Initiated
- 2015-12-21
- Posted
- 2016-01-30
- Terminated
- 2016-08-18
- Reason
- All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
- Root cause
- Packaging process control
- 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.
- Quantity
- 4,695
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- ["K980181"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28