FDA Recall Open, Classified

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

Recall: Z-1101-2022 · Initiated March 21, 2022

Recall

Recall Number: Z-1101-2022
Event Number: 89969
Firm: Windstone Medical Packaging, Inc.
FEI Number: 1000125955
Product Code: KDD
Status: Open, Classified
Root Cause: Nonconforming Material/Component
Initiated: March 21, 2022
Address: 1602 4th Ave N, Billings, MT, 59101-1521

Description

Reason

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.

Action

On 03/21/22, recall notices were emailed to customers who were informed that only the Prevantics swabs and/or swabsticks contained inside the kits are affected. All other components in the kits are not affected by the recall. The firm asked customers to overlabel affected kits with a label/sticker stating the reason for recall and providing instruction once the kit is opened for use; specifically the affected swab/swabsticks should be set aside, rendered unusable, and disposed of. Customers needing replacement swabs/swabsticks were asked to indicate this on the recall notice response form where they also indicate the number of kits present, which indicates how many labels/stickers are needed to overlabel the kits. Customers who have further distributed affected product were asked to identify their affected customers and notify them of the recall including a copy of the recall notice. All customers were asked to complete and return the response form. Customers with questions or concerns can contact the recalling firm at [email protected]

Distribution

US: PA, WA, FL, GA

Quantity

53,412