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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89969

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 21, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

1 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 1

Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tray Chicago/AMS10236A, Access Tray/AMS10238, Access Tray/AMS10238A, Access Tray/AMS10238B, Gray Pack/AMS10247, Gray Pack/AMS10247A, C-Access Tray/AMS10249, C-Access Tray/AMS10249A, C Access Tray/AMS10255, C Access Tray/AMS10255A, Jacksonville Tray/AMS10256, Jacksonville Tray/AMS10256A, Jacksonville Tray/AMS10256B, NVS Access Tray/AMS10257, AZ Access Tray/AMS10271, AZ Access Tray/AMS10271A, Fistulagram/ C-Access Pack/AMS10280, Fistulagram/ C-Access Pack/AMS10280A, Ultrasound Tray w/PDI/AMS10710A, Procedure Tray/AMS10897A, Universal Block Tray-RX/AMS12381, Ultrasound Injection-RX/AMS12382, Pellet Insertion Tray/AMS12735, PICC Insertion Tray - RX/AMS-7192CS-8, Breast Biopsy Tray/DDS1010G, Single Shot Epidural Tray-Rx/DDS1149, PICC Insertion Tray-RX/VYMAXBASIC

Z-1101-2022
Recall number
Z-1101-2022
Initiated
March 21, 2022
Classification
Class II
Status
Ongoing
Quantity
53,412

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.

Code information

AMS6569/ Between 142683 and 170329; AMS6570B/ Between 150682 and 170330; AMS6572A/Between 150863 and 170779; AMS6573/Between 153041 and 167712; AMS6828/Between 154460 and 165574; AMS6828A/167575, 168392; AMS9954/Between 152386 and 157483; AMS9954A/Between 157481 and 169200; AMS10234/Between 152202 and 159363; AMS10234A/Between 158104 and 169113; AMS10236/Between 152782 and 156962; AMS10236A/Between 157478 and 169198; AMS10238/Between 150032 and 160155; AMS10238A/Between 159664 and 166692; AMS10238B/Between 167164 and 168646; AMS10247/Between 146572 and 156705; AMS10247A/Between 157182 and 168754; AMS10249/Between 158599 and 161959; AMS10249A/Between 157256 and 169105; AMS10255/Between 150385, and 156000; AMS10255A/Between 157201 and 167493; AMS10256/153691; AMS10256A/Between 158498 and 163451; AMS10256B/Between 160447 and 169108; AMS10257/Between 158004 and 166979; AMS10271/150057; AMS10271A/Between 157910 and 168755; AMS10280/Between 150046 and 158682; AMS10280A/Between 157914 and 168539; AMS10710A/Between 154520 and 164202; AMS10897A/162161, 163158, 163524; AMS12381/Between 154627 and 156334; AMS12382/153165; AMS12735/164426; AMS-7192CS-8/155088, 156610, 156611; DDS1010G/153351, 157709, 157746; DDS1149/167640; VYMAXBASIC/Between 156613 and 165673

Distribution pattern

US: PA, WA, FL, GA