Windstone Recalls Angio Packs Due to Tubing Weld Defect
Windstone Medical Packaging recalls 114 Angio Pack kits (REF AMS6908C) due to insufficient angio tubing welds. Check lot numbers 146304 and 147534.
Use caution until it’s fixed
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Contact the company
What happened, in plain English
Windstone Medical Packaging, Inc. is recalling 114 units of its Angio Pack Custom Convenience Kits because the included Angio tubing may have an insufficient or incomplete weld. The affected kits were distributed nationwide in Arizona. No remedy information is currently provided in the record. Read more at govinfonow.com/recall/62818-windstone-medical-angio-pack-recalls-insufficient-angio-tubing-welds.
Source Summary by GovInfoNow · govinfonow.com/recall/62818-windstone-medical-angio-pack-recalls-insufficient-angio-tubing-welds · Updated October 13, 2026 · FDA enforcement record: FDA #Z-1848-2021
Cite this page
“Windstone Recalls Angio Packs Due to Tubing Weld Defect.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/62818-windstone-medical-angio-pack-recalls-insufficient-angio-tubing-welds. Based on FDA recall #Z-1848-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1848-2021%22&limit=1).
Why it’s dangerous
The defect involves a potential failure point in the Angio tubing due to an insufficient or incomplete weld. While the specific injury mechanism is not detailed, a compromised weld in medical tubing can lead to leaks or disconnection during use, which poses a risk to patient safety during procedures.
Who’s affected
Medical facilities or professionals in Arizona who purchased Windstone Medical Packaging's Custom Convenience Kits with reference number AMS6908C between the production dates of lots 146304 and 147534.
How to tell if you have this one
Look for the reference number AMS6908C on the packaging. Check the lot numbers printed on the kit; the recalled items are specifically from lots 146304 and 147534. The product is a sterile EO Angio Pack containing various surgical supplies like scalpels, guidewires, and tubing.
- Brand
Windstone Medical Packaging- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide distribution in the state of AZ.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1848-2021 | 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 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB 22x 1.5 1 Spike Bag decanter 6 Syringe 10cc L/L 10 Towel or Blue 2 Bag Band 36 X 50 W/TP 1 Prep Ultra Sound Gel Packet 1 Bowl Denture Cup 8 oz (250C 1 Bowl 32 oz (1000CC) 1 Cover Set UP 54X90 1 Instr Forcep Kelly Strt 5.5 1 Angio Tubing HP 10 W/ROT M/L 1 Needle Introducer 21G 1 Dressing Telfa 3X4 2 Syringe 20cC L/L 1 Guidewire Nitinol .018X45CM 1 Drape Angio 80 X 125 W/2 WIN 1 Introducer 5F X 10CM Stiff.; Lot Number 146304 and 147534 | 114 units |
| Z-1849-2021 | 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 (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3; Lot Number 146305, 147637, 148389, and 148814 | 190 units |
What to do — step by step
Identify the Kit
Check if you have an Angio Pack with REF AMS6908C and lot numbers 146304 or 147534.
Contact Manufacturer
Since the remedy is not stated in the record, contact Windstone Medical Packaging, Inc. directly for instructions on how to proceed with these specific lots.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of AZ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where were these recalled kits sold?
The record states there was US Nationwide distribution in the state of AZ.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1848-2021 (April 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1848-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.