CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
Self-Righting Luer Lock Tip Cap, Green recalled
Baxter Corporation Englewood is recalling Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, distributed in Illinois, Texas, Utah, Virginia. The recall was initiated on 4 Dec 2014 and the FDA has classified it as Class II.
Check your package
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-0871-2015
- FDA event ID
- 69934
- Recalling firm
- Baxter Corporation Englewood, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2014
- FDA classified
- 24 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 4 Dec 2014 | Recall initiated by company | |
| 24 Dec 2014 | Classified by FDA | +20 days |
| 31 Dec 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
Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile
Where it was distributed
Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.
Questions about this recall
Why was it recalled?
Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.
Which lots are affected?
Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365
Where was it sold?
Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.
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 |
|---|---|---|---|---|---|
| Device | CLASS I | 0.2 Micron Filter recalled by Baxter Corporation Englewood | Baxter Corporation Englewood | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter, Rapidfill Syringe Strip For use recalled | Baxter Corporation Englewood | Packaging Defects | Nationwide |
| Device | CLASS II | Abacus SE (Single-Workstation Edition) and Abacus ME recalled | Baxter Corporation Englewood | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter, Self-Righting Syringe Tip Caps recalled | Baxter Corporation Englewood | Other | Nationwide |
| Device | CLASS II | Abacus 3.1, Pharmacy Calculator recalled by Baxter Corporation Englewood | Baxter Corporation Englewood | Device Malfunction | Nationwide |
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