Recall Z-1620-2014— Baxter Corporation Englewood
Class II · Terminated
Class II FDA medical device recall by Baxter Corporation Englewood, initiated 2014-04-16, terminated 2015-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Possible breach in sterile barrier for inner and outer bags of the product..
- Recalling firm
- Baxter Corporation Englewood
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-16
- Terminated
- 2015-03-23
- Firm location
- Englewood, CO, United States
Product description
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.
Reason for recall
Possible breach in sterile barrier for inner and outer bags of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.