The Recall Desk
HighFDA (Devices)·Z-1848-2021·Announced 2021-06-23

Surgical Angio Pack Kits Recalled Due to Incomplete Angio Tubing Weld

Windstone Medical Packaging is recalling Angio Pack surgical kits (Lot 146304 and 147534) due to angio tubing with insufficient or incomplete welds.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II without reported illnesses or injuries. Incomplete weld is a structural defect in surgical tubing, constituting a risk-of-harm medical device where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Angio Pack REF: AMS6908C surgical convenience kits. This recall affects 114 units with Lot Numbers 146304 and 147534, distributed nationwide in Arizona.

The angio tubing included in these kits may contain insufficient or incomplete welds. A defective weld could compromise the integrity and function of the tubing during angiography procedures.

Healthcare facilities and medical professionals should be aware of this defect and verify lot numbers in their inventory. For additional information, refer to FDA recall number Z-1848-2021.

The recalled product

Product
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical / Angiography Kit
Hazard
  • incomplete-weld
  • structural-defect

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 (1)

  • Lot Number 146304 and 147534

Distribution

Distributed nationwide across the United States.

Related recalls

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