medical Class II Updated 2022-05-25

Windstone Medical Packaging, Inc. recalls Prevantics swabs and/or swabsticks contained inside the foll

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: PA, WA, FL, GA
Lot/Code Info: 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
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