Recalls / —

—#205486

Product

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

FDA product code

KDD — Kit, Surgical Instrument, Disposable

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297

Why it was recalled

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

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm

Windstone Medical Packaging, Inc.

Address

1602 4th Ave N, Billings, Montana 59101-1521

Distribution

Distribution pattern

US: FL, IL, CA OUS: None

Timeline

Recall initiated

2023-12-22

Posted by FDA

2024-02-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #205486. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.