The Recall Desk
HighFDA (Devices)·Z-1849-2021·Announced 2021-06-23

Angio Pack surgical kits recalled for insufficient welds in tubing

Windstone Medical Packaging is recalling Angio Pack surgical kits containing angio tubing with incomplete or insufficient welds that may fail during use. The recall affects 190 units; no injuries have been reported.

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: This is an FDA Class II recall involving a structural defect (incomplete welds) in medical tubing used in vascular procedures. Although no injuries or adverse events have been reported, the defect presents a risk of device failure during use, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Angio Pack surgical kits (Model/Ref: AMS8050A) due to angio tubing that may contain insufficient or incomplete welds. The affected products are sterile, pre-assembled kits containing surgical instruments and supplies used in angiography procedures.

The incomplete or insufficient welds in the angio tubing could potentially fail or disconnect during use, compromising the integrity of the device during a vascular procedure. No injuries or adverse events have been reported as of this recall announcement.

The recall affects 190 units distributed nationwide in Arizona. Affected lot numbers are 146305, 147637, 148389, and 148814. Healthcare facilities and medical professionals who have received these kits should immediately discontinue use and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kit / Angiography
Hazard
Affected units
190

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 (4)

  • Lot Number 146305
  • 147637
  • 148389
  • and 148814

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · incomplete weld

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