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U.S. Department of Health and Human Services

Class 1 Device Recall In House Ocular Pack

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  Class 1 Device Recall In House Ocular Pack see related information
Date Initiated by Firm December 22, 2023
Date Posted February 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1081-2024
Recall Event ID 93807
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Code Information UDI: B098AMS129470/ Lot #s: 192389 and 194805
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information Contact Vicki Davis
406-259-6387
Manufacturer Reason
for Recall		 Sterility assurance for saline included in surgical kits cannot be guaranteed.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 80 kits
Distribution US: FL, IL, CA OUS: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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