Z-1079-2024Class I

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

Name: Z-1079-2024 Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Creator: Windstone Medical Packaging, Inc.
Published: 2023-12-22
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2023-12-22 / Open, Classified / root cause: sterility

FDA source

Windstone Medical Packaging, Inc. began a recall of Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO on 2023-12-22. FDA classified it as Class I and gives the reason as "Sterility assurance for saline included in surgical kits cannot be guaranteed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1079-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-22
Posted: 2024-02-16
Recalling firm: Windstone Medical Packaging, Inc.
Product: Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Sterility assurance for saline included in surgical kits cannot be guaranteed.
Root cause tag: sterility
FDA root cause: 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 [email protected] 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: 1,528 units
Distribution: US: FL, IL, CA OUS: None
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1079-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1079-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1080-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1081-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1082-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)