Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS104

FDA device recall Z-0881-2023 · posted 2023-01-04 · Open, Classified

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

Reason for recall

Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.

Action taken

On 11/01/2022, firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that Align Medical Solutions Convenience Kits were being recalled due to kits containing 3M Steri-Drape Surgical Drapes that have an adhesive component that is difficult to remove without damaging the drape and may render the product unusable. Customers are instructed to: 1. Immediately check their inventory and place affected products under quarantine. 2. Due to the manufacturing process, any finished sterilized packs remaining in inventory, or at their facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack that reads: RECALL NOTICE - 3M announced the recall of 3M Steri-Drape Surgical Drape(s) contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. 1. At the time the kit is opened for use any 3M Steri-Drape Surgical Drape(s) should be identified and set aside. 2. The recalled 3M Steri-Drape Surgical Drape(s) should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. For questions or concerns contact - fieldcorrectiveaction@alignedmedicalsolutions.com or vdavis@alignedmedicalsolutions.com

Root cause

Component change control

Status

Open, Classified

Product code

KDD

Quantity affected

9,489 kits

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of Canada.

Date initiated

2022-11-01

Date posted

2023-01-04

Location

Billings, MT