—#200145

Product

Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

FDA product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 188843; UDI: B098AMS4601E0

Why it was recalled

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

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Windstone Medical Packaging, Inc.
Address: 1602 4th Ave N, Billings, Montana 59101-1521

Distribution

Distribution pattern: US: MA OUS: None

Timeline

Recall initiated: 2023-04-24
Posted by FDA: 2023-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.