Food, drugs, devices › Windstone Medical Packaging, Inc.

Device recall: AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

FDA enforcement event 78366 · Class II · initiated 24 Oct 2017 · status Terminated · terminated 2 Jul 2018

DeviceVoluntary: Firm initiated1 product recordBillings, MT

FDA enforcement event 78366 is a device recall by Windstone Medical Packaging, Inc. of Billings, MT, initiated 24 Oct 2017 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 2 Jul 2018. Initiation: voluntary: firm initiated. Windstone Medical Packaging, Inc. has 20 enforcement events on this register, with a median of 3 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Windstone Medical Packaging, Inc., Billings, MT.

Reason for recall

"Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach."

Distribution

"US Distribution to the state of : SC"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0069-2018	AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.	60 kits	Class II	Terminated	15 Nov 2017

Context

93%of 2017 device events are Class II1,091 events that year

1product record in this eventfirm median: 3

20events on this register for the firm

Other enforcement events for Windstone Medical Packaging, Inc.

Initiated	Product (first record)	Type	Class	Records
29 Jul 2026	AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B	Device	Class II	1
17 Jun 2026	AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A	Device	Class II	8
8 Jun 2026	AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part	Device	Class II	4
21 May 2026	A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit	Device	Class I	4
27 Apr 2026	Aligned Medical AMS16835 Fluids Kit RX	Device	Class II	1
2 Apr 2026	Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S	Device	Class I	1
11 Mar 2026	Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433	Device	Class II	3
16 Aug 2024	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a c	Device	Class II	5
22 Dec 2023	Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO	Device	Class I	4
24 Apr 2023	Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO	Device	Class II	3

All 20 events for Windstone Medical Packaging, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution to the state of : SC"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 2 Jul 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.