CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report

Baxter, Self-Righting Syringe Tip Caps recalled

Baxter Corporation Englewood is recalling Baxter, Self-Righting Syringe Tip Caps, Self-Righting Discpac Syringe Tip Caps, distributed nationwide in the US. The recall was initiated on 29 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll DiscPac products are affected within expiry up to October 2017

Quantity recalled1,404,230

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-1227-2015
FDA event ID: 70128
Recalling firm: Baxter Corporation Englewood, Englewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 29 Dec 2014
FDA classified: 27 Feb 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

29 Dec 2014	Recall initiated by company
27 Feb 2015	Classified by FDA	+60 days
11 Mar 2015	Published in enforcement report	+12 days

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

Reason for recall

Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

Product as listed by the FDA

Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

Which lots are affected?

All DiscPac products are affected within expiry up to October 2017

Where was it sold?

Nationwide Distribution

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
31 Dec 2014Device	CLASS II	Self-Righting Luer Lock Tip Cap, Green recalled	Baxter Corporation Englewood	Foreign Material	4 states
2 Jul 2014Device	CLASS II	Abacus 3.1, Pharmacy Calculator recalled by Baxter Corporation Englewood	Baxter Corporation Englewood	Device Malfunction	Nationwide

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