Recall Z-1079-2024 ยท KDD Kit, Surgical Instrument, Disposable
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
| Date | Feb 16, 2024 (initiated Dec 22, 2023) |
| Status | Open, Classified |
| Reason | Sterility assurance for saline included in surgical kits cannot be guaranteed. |
| Root cause | Unknown/Undetermined by firm |
| Action | On January 22, 2024, Windstone Medical Packaging dba Aligned Medical Solutions (AMS) On December 22, 2023, Windstone Medical Packaging dba Aligned Medical Solutions (AMS) issued an "Urgent: Medical Device Recall notice via. E-Mail. AMS asked consignees to take the following actions: 1. Immediately check your inventory for the voluntary recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. 3. Complete th |
| Quantity | 1,528 units |
| Distribution | US: FL, IL, CA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.