Recall Z-1848-2021 ยท KDD Kit, Surgical Instrument, Disposable
Windstone Medical Packaging, Inc.
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 backt
| Date | Apr 8, 2021 |
| Status | Terminated |
| Reason | Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld |
| Root cause | Unknown/Undetermined by firm |
| Action | On March 26, 2021, Windstone Medical Packaging dba Aligned Medical Solutions issued a "Urgent Medical Device Recall notification to affected consignees via US Mail. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Due to the manufacturing process and finished sterilized packs, if any, in inventory, or at your facility, over labeling of inventory affected by this recall will be labeled with a sticker attached to each pack. The sticker will read: "Recall Notice Smith Medical announced the recall of the angio tubing contained |
| Quantity | 114 units |
| Distribution | US Nationwide distribution in the state of AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.