FDA Recall Open, Classified

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 AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack

Recall: Z-0881-2023 · Initiated November 1, 2022

Recall

Recall Number: Z-0881-2023
Event Number: 91157
Firm: Windstone Medical Packaging, Inc.
FEI Number: 1000125955
Product Code: KDD
Status: Open, Classified
Root Cause: Component change control
Initiated: November 1, 2022
Posted: January 4, 2023
Address: 1602 4th Ave N, Billings, MT, 59101-1521

Description

Reason

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

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 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 - [email protected] or [email protected]

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.

Quantity

9,489 kits