Device recall: Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room

Class II FDA enforcement event 71968. Recall start date: 22 Apr 2015. Status in the FDA record: Terminated. Termination date: 25 Oct 2016.

Reason for recall, in the words of FDA

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Class II, in the words of FDA

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

Windstone Medical Packaging, Inc. started this device recall on 22 Apr 2015. The firm address in the FDA record is in Billings, MT. FDA put the recall in Class II. FDA event 71968 has 150 product records. The first FDA enforcement report date is 26 Oct 2016. The record gives the status Terminated, with the termination date 25 Oct 2016.

FDA enforcement report The 150 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Recalling firm

Windstone Medical Packaging, Inc., Billings, MT.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

150 product records in the event.

FDA event 71968: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0139-2017	Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room	15 kits	Class II	Terminated	26 Oct 2016
Z-0140-2017	Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room	192 kits	Class II	Terminated	26 Oct 2016
Z-0141-2017	Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room	93 kits	Class II	Terminated	26 Oct 2016
Z-0142-2017	Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room	5723 kits	Class II	Terminated	26 Oct 2016
Z-0143-2017	Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room	132 kits	Class II	Terminated	26 Oct 2016
Z-0144-2017	Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room	20 kits	Class II	Terminated	26 Oct 2016
Z-0145-2017	Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room	2266 kits	Class II	Terminated	26 Oct 2016
Z-0146-2017	Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room	53 kits	Class II	Terminated	26 Oct 2016
Z-0147-2017	Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room	6381 kits	Class II	Terminated	26 Oct 2016
Z-0148-2017	Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room	256 kits	Class II	Terminated	26 Oct 2016
Z-0149-2017	Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room	1599 kits	Class II	Terminated	26 Oct 2016
Z-0150-2017	Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room	1243 kits	Class II	Terminated	26 Oct 2016
Z-0151-2017	Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room	90 kits	Class II	Terminated	26 Oct 2016
Z-0152-2017	Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room	312 kits	Class II	Terminated	26 Oct 2016
Z-0153-2017	Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room	10 kits	Class II	Terminated	26 Oct 2016
Z-0154-2017	Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room	288 kits	Class II	Terminated	26 Oct 2016
Z-0155-2017	Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room	1498 kits	Class II	Terminated	26 Oct 2016
Z-0156-2017	Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room	505 kits	Class II	Terminated	26 Oct 2016
Z-0157-2017	Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room	288 kits	Class II	Terminated	26 Oct 2016
Z-0158-2017	C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room	48 kits	Class II	Terminated	26 Oct 2016
Z-0159-2017	C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room	268 kits	Class II	Terminated	26 Oct 2016
Z-0160-2017	C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room	186 kits	Class II	Terminated	26 Oct 2016
Z-0161-2017	Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room	138 kits	Class II	Terminated	26 Oct 2016
Z-0162-2017	Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room	246 kits	Class II	Terminated	26 Oct 2016
Z-0163-2017	Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room	102 kits	Class II	Terminated	26 Oct 2016
Z-0164-2017	Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room	546 kits	Class II	Terminated	26 Oct 2016
Z-0165-2017	Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room	6526 kits	Class II	Terminated	26 Oct 2016
Z-0166-2017	Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room	1470 kits	Class II	Terminated	26 Oct 2016
Z-0167-2017	Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room	56 kits	Class II	Terminated	26 Oct 2016
Z-0168-2017	Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room	1584 kits	Class II	Terminated	26 Oct 2016
Z-0169-2017	D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room	592 kits	Class II	Terminated	26 Oct 2016
Z-0170-2017	D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room	615 kits	Class II	Terminated	26 Oct 2016
Z-0171-2017	D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room	56 kits	Class II	Terminated	26 Oct 2016
Z-0172-2017	DND Pack, Kit number AMS3846 convenience custom kits used for general surgery in hospital operating room	108 kits	Class II	Terminated	26 Oct 2016
Z-0173-2017	Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room	360 kits	Class II	Terminated	26 Oct 2016
Z-0174-2017	Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room	648 kits	Class II	Terminated	26 Oct 2016
Z-0175-2017	Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room	48 kits	Class II	Terminated	26 Oct 2016
Z-0176-2017	Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general surgery in hospital operating room	40 kits	Class II	Terminated	26 Oct 2016
Z-0177-2017	Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room	120 kits	Class II	Terminated	26 Oct 2016
Z-0178-2017	Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room	2048 kits	Class II	Terminated	26 Oct 2016
Z-0179-2017	Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room	666 kits	Class II	Terminated	26 Oct 2016
Z-0180-2017	Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room	304 kits	Class II	Terminated	26 Oct 2016
Z-0181-2017	ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room	123 kits	Class II	Terminated	26 Oct 2016
Z-0182-2017	ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room	1795 kits	Class II	Terminated	26 Oct 2016
Z-0183-2017	Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room	3829 kits	Class II	Terminated	26 Oct 2016
Z-0184-2017	Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room	290 units	Class II	Terminated	26 Oct 2016
Z-0185-2017	Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room	816 kits	Class II	Terminated	26 Oct 2016
Z-0186-2017	Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room	720 kits	Class II	Terminated	26 Oct 2016
Z-0187-2017	Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room	802 kits	Class II	Terminated	26 Oct 2016
Z-0188-2017	Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room	27 kits	Class II	Terminated	26 Oct 2016
Z-0189-2017	Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room	111 kits	Class II	Terminated	26 Oct 2016
Z-0190-2017	Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room	282 kits	Class II	Terminated	26 Oct 2016
Z-0191-2017	Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room	85 kits	Class II	Terminated	26 Oct 2016
Z-0192-2017	General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room	26 kits	Class II	Terminated	26 Oct 2016
Z-0193-2017	General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room	1596 kits	Class II	Terminated	26 Oct 2016
Z-0194-2017	General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room	1596 kits	Class II	Terminated	26 Oct 2016
Z-0195-2017	General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room	135 kits	Class II	Terminated	26 Oct 2016
Z-0196-2017	General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room	1378 kits	Class II	Terminated	26 Oct 2016
Z-0197-2017	General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room	985 kits	Class II	Terminated	26 Oct 2016
Z-0198-2017	General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room	168 kits	Class II	Terminated	26 Oct 2016

The table shows 60 of 150 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 150Median of the firm: 3
Events of the firm on the register: 20

Other events of the firm

Other FDA enforcement events of 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

Windstone Medical Packaging, Inc.: all 20 events

Official channels

FDA enforcement report Z-0139-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 71968. https://recallregister.com/fda/ii/71968/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
What quantity of product is in FDA event 71968?: The event has 150 product records. The first record gives this quantity: 15 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.