Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

FDA device recall Z-1079-2024 · posted 2024-02-16 · Open, Classified

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

Reason for recall

Sterility assurance for saline included in surgical kits cannot be guaranteed.

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.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

KDD

Quantity affected

1,528 units

Distribution

US: FL, IL, CA OUS: None

Date initiated

2023-12-22

Date posted

2024-02-16

Location

Billings, MT