Z-0731-2016Class II

Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

Name: Z-0731-2016 Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Creator: Baxter Corporation Englewood
Published: 2015-12-21
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2015-12-21 / Terminated / root cause: packaging

FDA source

Baxter Corporation Englewood began a recall of Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF) on 2015-12-21. FDA classified it as Class II and gives the reason as "All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0731-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Posted: 2016-01-30
Terminated: 2016-08-18
Recalling firm: Baxter Corporation Englewood
Product: Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Product code: FMF Syringe, Piston
Reason for recall: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
Root cause tag: packaging
FDA 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 in commerce: 4,695
Distribution: Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0731-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0731-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30

Product code FMF

K980181Class IITerumo Disposable Hypodermc SyringeTerumo Medical Corp. / cleared 1998-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)