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FDA (Device enforcement)Recalled 2022-07-22class ii

Baxter Healthcare Corporation: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100

Is my product affected?

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100

  • UPC 00085412479965
  • UPC 00085412479798

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling Baxter DISCPAC Syringe Tip Caps in two package sizes: 25-packs (REF H938693025) and 100-packs (REF H938673100), across all lots. The recall affects approximately 24,320 units distributed worldwide, including throughout the United States and in Australia, Finland, Germany, Spain, and the United Kingdom. The product is being recalled because the packaging may not maintain a sterile barrier for the tip caps.

This recall involves syringe tip caps that are self-righting with a Luer slip design in dark blue color. Since the packaging may have failed to maintain sterility, the affected tip caps could be compromised for medical use. The source document does not specify a remedy or corrective action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Details from the source

Reason for recall: There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Distribution: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom. Quantity: 24,320 units Lot/code info: a) 25 pack REF H938693025, UDI 00085412479965, ALL LOTS; b) 100 pack REF H938673100, UDI 00085412479798, ALL LOTS

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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