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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 114
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
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.
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