Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
- Recall Initiated
- December 22, 2023
- Posted
- February 16, 2024
- Recall Number
- Z-1082-2024
- Quantity
- 475 kits
- Firm Location
- Billings, MT
Reason for Recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Distribution
US: FL, IL, CA OUS: None
Lot / Code Info
UDI: B098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864
Root Cause
Unknown/Undetermined by firm
Action Taken
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 vdavis@alignedmedicalsolutions.com even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement Nurse Assist product is needed.