Class 2 Device Recall Angio Pack

• Date Initiated by Firm: April 08, 2021
• Create Date: June 11, 2021
• Recall Status: Terminated on December 15, 2022
• Recall Number: Z-1848-2021
• Recall Event ID: 87859
• Product Classification: Kit, surgical instrument, disposable - Product Code KDD
• Product: Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB 22x 1.5 1 Spike Bag decanter 6 Syringe 10cc L/L 10 Towel or Blue 2 Bag Band 36 X 50 W/TP 1 Prep Ultra Sound Gel Packet 1 Bowl Denture Cup 8 oz (250C 1 Bowl 32 oz (1000CC) 1 Cover Set UP 54X90 1 Instr Forcep Kelly Strt 5.5 1 Angio Tubing HP 10 W/ROT M/L 1 Needle Introducer 21G 1 Dressing Telfa 3X4 2 Syringe 20cC L/L 1 Guidewire Nitinol .018X45CM 1 Drape Angio 80 X 125 W/2 WIN 1 Introducer 5F X 10CM Stiff.
• Code Information: Lot Number 146304 and 147534
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• For Additional Information Contact: Vicki Davis; 407-638-9924
• Manufacturer Reason for Recall: Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On March 26, 2021, Windstone Medical Packaging dba Aligned Medical Solutions issued a "Urgent Medical Device Recall notification to affected consignees via US Mail. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Due to the manufacturing process and finished sterilized packs, if any, in inventory, or at your facility, over labeling of inventory affected by this recall will be labeled with a sticker attached to each pack. The sticker will read: "Recall Notice Smith Medical announced the recall of the angio tubing 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 angio tubing manufactured by Smith Medical should be identified and set aside, 2 The recalled tubing should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. 2. Please complete the attached AMS recall reply form and return it to Aligned Medical Solutions at the Fax number provided on the form. If you do not have the affected product you must complete and return the AMS Recall Reply Form. replacement product will be issued upon request and completion of the attached Recall Reply For. 3 If you have any questions or concerns, please contact Vicki Davis, Quality Manager, 407-638-9924
• Quantity in Commerce: 114 units
• Distribution: US Nationwide distribution in the state of AZ.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.