Z-1091-2021Class II

Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are...

Name: Z-1091-2021 Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are...
Creator: Cardinal Health 200, LLC
Published: 2021-01-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-01-07 / Open, Classified

FDA source

Cardinal Health 200, LLC began a recall of 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... on 2021-01-07. FDA classified it as Class II and gives the reason as "There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1091-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-07
Posted: 2021-02-05
Recalling firm: Medtronic, Inc.
Product: 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 expected.
Product code: OEA Non-Surgical Gown
Reason for recall: There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
FDA root cause: Process change control
Action: The firm, CardinalHealth, sent "URGENT MEDICAL DEVICE RECALL" notification letters dated 1/7/21 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Actions requested on your part: 1) REVIEW your inventory for affected product. 2) SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Attachment 1. 3) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product action. 4) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmb- [email protected], whether or not you have affected product. 5) CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other Customers888-444-5440 6) CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other customers888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.
Quantity in commerce: 29,810,665 total
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, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.
Product codes and lots: All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1091-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1085-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1086-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1087-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1088-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1089-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1090-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1091-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1092-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1093-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1094-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1095-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1096-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1097-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-05

Product code OEA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)