Baxter Recalls Self-Righting Luer Tip Caps Due to Validation Timing
Baxter Corporation is recalling two lots of sterile syringe tip caps because they were distributed before the completion of a required validation process.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or specific safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Corporation has initiated a recall of two specific lots of Self-Righting Luer Lock Tip Caps (Green) and Self-Righting Luer Slip Tip Caps (Yellow). The affected products are sterile DISCPAC Syringe Tip Caps manufactured by Baxter Healthcare Corporation in Englewood, Colorado. The recall involves Product Code H93869100, Lot 1001380, and Product Code H93866100, Lot 1001365.
The reason for the recall is that these products were distributed prior to the closure of the validation process. The source text does not specify the nature of the validation or any specific defects, but indicates a procedural timing issue regarding the release of the product.
Approximately 54,000 units were distributed worldwide. In the United States, distribution was limited to the states of Utah, Texas, and Illinois. Internationally, the products were distributed to Austria, Germany, Spain, Switzerland, and the Netherlands. The source notes that there were no VA, military, or government consignees. Consumers and healthcare providers should check their inventory for these specific product codes and lot numbers and contact Baxter Corporation for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Baxter Corporation Englewood
- Hazard
- Affected units
- 54,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code H93869100
- Lot 1001380 and Product Code H93866100
- Lot 1001365
Distribution
Distributed in 1 state:
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