Recall Z-0881-2023 ยท KDD Kit, Surgical Instrument, Disposable
Windstone Medical Packaging, Inc.
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack
| Date | Jan 4, 2023 (initiated Nov 1, 2022) |
| Status | Open, Classified |
| Reason | Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare. |
| Root cause | Component change control |
| Action | 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 lab |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.