The Recall Desk
ModerateFDA (Devices)·Z-1576-2022·Announced 2022-08-31

Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Failure

Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging defects that may not maintain sterile barriers. The recall affects approximately 63,190 units distributed worldwide.

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: This is a Class II recall with no reported illnesses or injuries. The hazard is described as potential and theoretical (packaging may not maintain sterile barrier), and the recall is precautionary in nature. Per the rubric, when a hazard is theoretical with no reported incidents, the score is at most 3; this case fits the criteria for a precautionary recall at Score 2.

Plain-English summary

Baxter Healthcare Corporation is recalling approximately 63,190 units of DISCPAC Syringe Tip Caps (Self-Righting, Luer Slip, Orange) due to a potential defect in product packaging. The issue involves the packaging's ability to maintain a sterile barrier protecting the tip caps.

The affected products include two pack sizes: the 25-pack (REF H93867025) and 100-pack (REF H93867100). All lots of both products are included in this recall. The products have been distributed worldwide, including throughout the United States and internationally in Australia, Finland, Germany, Spain, and the United Kingdom.

Healthcare providers and other recipients of these products should stop using the affected syringe tip caps and contact Baxter Healthcare Corporation for replacement or return instructions.

The recalled product

Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
Manufacturer
Baxter Healthcare Corporation
Hazard
  • sterile-barrier-failure
  • contamination-risk

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 (5)

  • a) REF H93867025
  • UDI 00085412478869
  • ALL LOTS
  • b) REF H93867100
  • UDI 00085412478890

Distribution

Distributed nationwide across the United States.