Windstone Medical Packaging, Inc.: Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3

Recall number

Z-1849-2021

Recalling firm

Windstone Medical Packaging, Inc.

Product

Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3

Status

Terminated

Initiated

2021-04-08

Posted

not on file

Terminated

2022-12-15

Reason

Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

Root 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

190 units

Distribution

US Nationwide distribution in the state of AZ.

Lot, serial or model codes

Lot Number 146305, 147637, 148389, and 148814

510(k) numbers

not on file

PMA numbers

not on file

Product code

KDD

Firm FEI

1000125955

Firm city

Billings

Firm state

MT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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