Reported May 25, 2022 · Ongoing
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with…
Windstone Medical Packaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521
Is this the product you have?
- Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions
- convenience kits with Name/Pack numbers
Ports Cath Pack (1794)/AMS6569Minor Procedure Pack (20527)/AMS6570BBreast Biopsy Pack (24771)/AMS6572ABone Marrow Pack (11862)/AMS6573Ultrasound Biopsy Pack -Rx/AMS6828Ultrasound Biopsy Pack -Rx/AMS6828AC Access Tray/AMS9954C Access Tray/AMS9954AAccess Tray A/AMS10234Access Tray A/AMS10234AC-Access Tray Chicago/AMS10236C-Access Tray Chicago/AMS10236AAccess Tray/AMS10238Access Tray/AMS10238AAccess Tray/AMS10238BGray Pack/AMS10247Gray Pack/AMS10247AC-Access Tray/AMS10249C-Access Tray/AMS10249AC Access Tray/AMS10255C Access Tray/AMS10255AJacksonville Tray/AMS10256Jacksonville Tray/AMS10256AJacksonville Tray/AMS10256BNVS Access Tray/AMS10257AZ Access Tray/AMS10271AZ Access Tray/AMS10271AFistulagram/ C-Access Pack/AMS10280Fistulagram/ C-Access Pack/AMS10280AUltrasound Tray w/PDI/AMS10710AProcedure Tray/AMS10897AUniversal Block Tray-RX/AMS12381Ultrasound Injection-RX/AMS12382Pellet Insertion Tray/AMS12735PICC Insertion Tray - RX/AMS-7192CS-8Breast Biopsy Tray/DDS1010GSingle Shot Epidural Tray-Rx/DDS1149PICC Insertion Tray-RX/VYMAXBASIC
- Lot codes and dates
38 of 38 products
Products covered by this recall # Product as published 1 AMS6569/ Between 142683 and 170329 2 AMS6570B/ Between 150682 and 170330 3 AMS6572A/Between 150863 and 170779 4 AMS6573/Between 153041 and 167712 5 AMS6828/Between 154460 and 165574 6 AMS6828A/167575, 168392 7 AMS9954/Between 152386 and 157483 8 AMS9954A/Between 157481 and 169200 9 AMS10234/Between 152202 and 159363 10 AMS10234A/Between 158104 and 169113 11 AMS10236/Between 152782 and 156962 12 AMS10236A/Between 157478 and 169198 13 AMS10238/Between 150032 and 160155 14 AMS10238A/Between 159664 and 166692 15 AMS10238B/Between 167164 and 168646 16 AMS10247/Between 146572 and 156705 17 AMS10247A/Between 157182 and 168754 18 AMS10249/Between 158599 and 161959 19 AMS10249A/Between 157256 and 169105 20 AMS10255/Between 150385, and 156000 - Amount recalled
- 53,412
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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