Device recall: Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown…

Class II FDA enforcement event 87134. Recall start date: 7 Jan 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

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 200, LLC started this device recall on 7 Jan 2021. The firm address in the FDA record is in Waukegan, IL. FDA put the recall in Class II. FDA event 87134 has 13 product records. The first FDA enforcement report date is 17 Feb 2021. The record gives the status Ongoing.

FDA enforcement report The 13 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.

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI,…

Recalling firm

Cardinal Health 200, LLC, Waukegan, IL.

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

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

Products

13 product records in the event.

FDA event 87134: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1085-2021	Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1086-2021	Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1087-2021	Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1088-2021	Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1089-2021	Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1090-2021	Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1091-2021	Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1092-2021	Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1093-2021	Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1094-2021	Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1095-2021	Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1096-2021	Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are…	29,810,665 total	Class II	Ongoing	17 Feb 2021
Z-1097-2021	Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.	29,810,665 total	Class II	Ongoing	17 Feb 2021

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 2021: 900
Share of these events in Class II: 89%
Product records in this event: 13Median of the firm: 3
Events of the firm on the register: 59

Other events of the firm

Other FDA enforcement events of Cardinal Health 200, LLC
Initiated	Product (first record)	Type	Class	Records
29 Jul 2026	Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catal	Device	Class II	12
14 Jul 2026	Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number:	Device	Class II	8
2 Mar 2026	Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Wa	Drug	Class I	1
27 Feb 2026	Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777	Device	Class II	1
26 Dec 2025	Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 888857	Device	Class II	1
12 Nov 2025	ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-st	Device	Class II	1
18 Sep 2025	Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SA	Device	Class II	6
13 May 2025	SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Con	Device	Class II	3
2 May 2025	Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs	Device	Class II	6
8 Nov 2024	Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGH	Device	Class II	10

Cardinal Health 200, LLC: all 59 events

Official channels

FDA enforcement report Z-1085-2021The 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 87134. https://recallregister.com/fda/ii/87134/. 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: Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI,…
What quantity of product is in FDA event 87134?: The event has 13 product records. The first record gives this quantity: 29,810,665 total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.