Device recall: AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA

Class II FDA enforcement event 84733. Recall start date: 11 Jan 2020. Status in the FDA record: Terminated. Termination date: 19 Jan 2023.

Reason for recall, in the words of FDA

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

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

Cardinal Health started this device recall on 11 Jan 2020. The firm address in the FDA record is in Waukegan, IL. FDA put the recall in Class II. FDA event 84733 has 39 product records. The first FDA enforcement report date is 12 Feb 2020. The record gives the status Terminated, with the termination date 19 Jan 2023.

FDA enforcement report The 39 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.

Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama,…

Recalling firm

Cardinal Health, Waukegan, IL.

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

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

Products

39 product records in the event.

FDA event 84733: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1002-2020	AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1003-2020	AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1004-2020	AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1005-2020	AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1006-2020	AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1007-2020	AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1008-2020	AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1009-2020	AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1010-2020	AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1011-2020	AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1012-2020	AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1013-2020	AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1014-2020	ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1015-2020	AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1016-2020	AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1017-2020	AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1018-2020	AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1019-2020	AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1020-2020	AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1021-2020	AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1022-2020	ROYALSILK LARGE, Gown. Item Code 9518	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1023-2020	ROYALSILK 2XLARGE, Gown. Item Code 9578	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1024-2020	ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1025-2020	AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1026-2020	AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1027-2020	ROYALSILK XLARGE, Gown. Item Code 9548	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1028-2020	AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1029-2020	AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1030-2020	AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1031-2020	AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1032-2020	GOWN SURG LG W/TOWEL ST BACK, Item Code 9515	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1033-2020	AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1034-2020	AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1035-2020	AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1036-2020	AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1037-2020	AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1038-2020	AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1039-2020	AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585	7,659,634 total units	Class II	Terminated	12 Feb 2020
Z-1040-2020	AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511	7,659,634 total units	Class II	Terminated	12 Feb 2020

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 2020: 916
Share of these events in Class II: 93%
Product records in this event: 39Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Cardinal Health
Initiated	Product (first record)	Type	Class	Records
1 Nov 2022	Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary dr	Device	Class II	6
2 Nov 2021	SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474	Device	Class II	11
4 Aug 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicat	Device	Class I	3
20 Jul 2016	BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Ste	Device	Class II	1
27 Jun 2016	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Me	Device	Class II	1
29 Feb 2016	Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of	Device	Class II	1
25 Aug 2015	Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for m	Device	Class II	1
23 Dec 2014	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is us	Device	Class II	1
2 Oct 2013	Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated ship	Drug	Class III	1
18 Dec 2012	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.	Device	Class II	9

Cardinal Health: all 12 events

Official channels

FDA enforcement report Z-1002-2020The 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 84733. https://recallregister.com/fda/ii/84733/. 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: Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama,…
What quantity of product is in FDA event 84733?: The event has 39 product records. The first record gives this quantity: 7,659,634 total units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.