Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 23, 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
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Windstone Medical Packaging, Inc. recalled Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire… - a moderate-severity action.
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire… was recalled by Windstone Medical Packaging, Inc. in June 23, 2021. Reason: Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld. Check the official notice for the remedy. Verify recall #Z-1848-2021 with the FDA Devices before acting.
The recall
Windstone Medical Packaging, Inc. issued this moderate-severity FDA Devices recall-Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld.
- Moderate
- severity level
- 114 units
- affected scope
- Class II
- classification
- June 23, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1848-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1848-2021) was formally reported on June 23, 2021, with the manufacturer initiating the action on April 8, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Windstone Medical Packaging, Inc. is listed as the recalling firm, operating out of Billings, MT. Federal records list the affected scope as 114 units.
The documented reason for this recall is: Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of AZ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
114 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1848-2021 |
| Date reported | June 23, 2021 |
| Date initiated | April 8, 2021 |
| Recalling firm | Windstone Medical Packaging, Inc. |
| Firm location | Billings, MT |
| Affected scope | 114 units |
| Distribution | US Nationwide distribution in the state of AZ. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1848-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Windstone Medical Packaging, Inc.. Units affected: 114 units.
Why was this product recalled? ▼
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1848-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of AZ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1848-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 23, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.