Z-1849-2021Class II

Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1...

Name: Z-1849-2021 Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1...
Creator: Windstone Medical Packaging, Inc.
Published: 2021-04-08
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2021-04-08 / Terminated / root cause: manufacturing process

FDA source

Windstone Medical Packaging, Inc. began a recall of 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... on 2021-04-08. FDA classified it as Class II and gives the reason as "Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1849-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-08
Posted: 2021-06-11
Terminated: 2022-12-15
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
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Root cause tag: manufacturing process
FDA 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 in commerce: 190 units
Distribution: US Nationwide distribution in the state of AZ.
Product codes and lots: Lot Number 146305, 147637, 148389, and 148814

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1849-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1848-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-11
Z-1849-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-11

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)