Class 2 Device Recall Aligned Medical Solutions Minor Hand Pack

• Date Initiated by Firm: April 24, 2023
• Date Posted: May 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1620-2023
• Recall Event ID: 92288
• Product Classification: Kit, surgical instrument, disposable - Product Code KDD
• Product: Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
• Code Information: Lot #s 187154 and 189008, UDI: B098AMS6539E0
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• For Additional Information Contact: Vicki Davis; 407-638-9924
• Manufacturer Reason for Recall: Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On April 24, 2023, Aligned Medical Solutions issued a "Urgent: Medical Device Recall" notification via E-Mail. Customers were asked 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 the all products affected by this recall. Packs will be labeled with a sticker attached to each pack. 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 products, 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 STERIS product is needed. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 90 kits
• Distribution: US: MA 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.