Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Recall
- Recall Number
- Z-1082-2024
- Event Number
- 93807
- Firm
- Windstone Medical Packaging, Inc.
- FEI Number
- 1000125955
- Product Code
- KDD
- Status
- Open, Classified
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- December 22, 2023
- Posted
- February 16, 2024
- Address
- 1602 4th Ave N, Billings, MT, 59101-1521
Description
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
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 the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. 4. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5. Please complete the Recall Reply Form within 5 business days and return via email to [email protected] even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement Nurse Assist product is needed.
US: FL, IL, CA OUS: None
475 kits