Aligned Medical AMS16835 Fluids Kit RX

FDA device recall Z-2307-2026 · posted 2026-06-03 · Open, Classified

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

Reason for recall

Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

Action taken

An URGENT: MEDICAL DEVICE RECALL dated 4/27/26 was sent to customers. Please Note: Since AMS manufactured convenience kits that contain Huons Co. Ltd. Pharmacy Lidocaine HCL 1% 5ML SDV, we are extending our recall strategy to the end user level. AMS requests that you undertake the following activities: 1. Immediately check your inventory for the 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. Packs will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE Huons Co. Ltd. announced the recall of 73293-0001-2 Lidocaine Hydrochloride Injection contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. " At the time the kit is opened for use any Huons Co. Ltd. Lidocaine Hydrochloride Injection should be identified, and quarantined. " The recalled Huons Co. Ltd. Lidocaine Hydrochloride Injection should be rendered unusable to protect against inadvertent use and returned to AMS. 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 fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement Huons Co. Ltd. product is needed. If you have any questions or concerns please do not hesitate to contact us at fieldcorrectiveaction@alignedmedicalsolutions.com. Dear Customer, This letter is to describe the process for placing the "Recall Notice

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LRO

Quantity affected

875 kits

Distribution

US Nationwide distribution in the states of IL, VA.

Date initiated

2026-04-27

Date posted

2026-06-03

Location

Billings, MT