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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87859

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 08, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Windstone Medical Packaging, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1848-2021
Recall number
Z-1848-2021
Initiated
April 08, 2021
Classification
Class II
Status
Terminated
Quantity
114 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

Code information

Lot Number 146304 and 147534

Distribution pattern

US Nationwide distribution in the state of AZ.

device · product 2 of 2

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

Z-1849-2021
Recall number
Z-1849-2021
Initiated
April 08, 2021
Classification
Class II
Status
Terminated
Quantity
190 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

Code information

Lot Number 146305, 147637, 148389, and 148814

Distribution pattern

US Nationwide distribution in the state of AZ.