CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report

Rapidfill Syringe Strip, For use recalled

Baxter Corporation Englewood is recalling Rapidfill Syringe Strip, For use with Rapidfill Automated Syringe Filler (Asf): H93890200, distributed in 21 states. The recall was initiated on 16 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: H93890200 Lots 787032 to 790790; Codes H93890221 Lots 789096 to 791247; Code H93890222 Lots 787761 to 790791; Code H93890223 Lots 786926 to 789793; Code H93890225 Lots 789794 to 790792; Code H93890227 Lots 789098 to 791246; Code H93890229 Lots 789637 to 790794; Code H93890231 Lots 788465 to 790795; Code H93890232 Lots 790796 to 791245

Quantity recalled774, 600

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1620-2014
FDA event ID: 68030
Recalling firm: Baxter Corporation Englewood, Englewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 16 Apr 2014
FDA classified: 14 May 2014
Reported: 21 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

16 Apr 2014	Recall initiated by company
14 May 2014	Classified by FDA	+28 days
21 May 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Possible breach in sterile barrier for inner and outer bags of the product.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syringe Strip, Gray. H93890232 RAPIDFILL Syringe Strip, Green. Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material.

Where it was distributed

Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada.

Alabama Arizona California Connecticut Florida Georgia Hawaii Illinois Kansas Massachusetts Michigan Minnesota Missouri North Carolina Nevada Ohio Oregon Pennsylvania Tennessee Virginia

Questions about this recall

Why was it recalled?

Possible breach in sterile barrier for inner and outer bags of the product.

Which lots are affected?

Product Code: H93890200 Lots 787032 to 790790; Codes H93890221 Lots 789096 to 791247; Code H93890222 Lots 787761 to 790791; Code H93890223 Lots 786926 to 789793; Code H93890225 Lots 789794 to 790792; Code H93890227 Lots 789098 to 791246; Code H93890229 Lots 789637 to 790794; Code H93890231 Lots 788465 to 790795; Code H93890232 Lots 790796 to 791245

Where was it sold?

Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Baxter Corporation Englewood

All 9

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016Device	CLASS I	0.2 Micron Filter recalled by Baxter Corporation Englewood	Baxter Corporation Englewood	Particulate Matter	Nationwide
10 Feb 2016Device	CLASS II	Baxter, Rapidfill Syringe Strip For use recalled	Baxter Corporation Englewood	Packaging Defects	Nationwide
27 May 2015Device	CLASS II	Abacus SE (Single-Workstation Edition) and Abacus ME recalled	Baxter Corporation Englewood	Device Malfunction	Nationwide
11 Mar 2015Device	CLASS II	Baxter, Self-Righting Syringe Tip Caps recalled	Baxter Corporation Englewood	Other	Nationwide
31 Dec 2014Device	CLASS II	Self-Righting Luer Lock Tip Cap, Green recalled	Baxter Corporation Englewood	Foreign Material	4 states

Other Syringes & Needles recalls

All 1,069

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Vacuette LH Lithium Heparin Separator recalled	Greiner Bio-One North America	Other	Nationwide
28 Oct 2026Device	CLASS II	Medtronic Biopsy Needle Kit recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
21 Oct 2026Device	CLASS II	Williams Cystoscopic Injection Needles, used recalled by Cook	Cook	Device Malfunction	5 states
7 Oct 2026Device	CLASS II	Embosphere 500-700 micrometer Syringe Sterile Steam recalled	Merit Medical Systems	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide