Z-2918-2020Class II

PROTEXIS Latex Micro Surgical Gloves Size 8.5 -

Name: Z-2918-2020 PROTEXIS Latex Micro Surgical Gloves Size 8.5 -
Creator: Cardinal Health 200, LLC
Published: 2020-07-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-07-29 / Completed

FDA source

Cardinal Health 200, LLC began a recall of PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber... on 2020-07-29. FDA classified it as Class II and gives the reason as "A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2918-2020
Classification: Class II
Status: Completed
Initiated: 2020-07-29
Posted: 2020-08-28
Recalling firm: Medtronic, Inc.
Product: PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
Product code: KGO Surgeon'S Gloves
Reason for recall: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
FDA root cause: Under Investigation by firm
Action: Cardinal Health distributed an urgent medical device recall letter dated July 29, 2020 to customers. This letter instructs customers to quarantine all effected product and return the response form to the firm. Product should be returned through the location from which it was purchased. An URGENT MEDICAL DEVICE RECALL EXPANSION dated 10/16/20 was sent to customers. The purpose of this notification is to notify that we are expanding the previous action to include additional production lots. Please see Attachment 1 for all affected product codes and lots (new lots in italics). The new product lots were distributed between April 2020 and September 2020. Actions requested on your part: 1) CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers listed in Attachment 1. Locations of codes are shown in Attachment 2. 2) SEGREGATE and QUARANTINE all impacted on-hand product. 3) RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email ([email protected]) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4) NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 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 related to this action: "
Quantity in commerce: 7119625 total
Distribution: US Nationwide distribution
Product codes and lots: Item Code: 2D72NT85X Lot #: TS19060044, TS19060122, TS19060189, TS19080111, TS19080184, TS19080227, TS19090008, TS19090127, TS19100079, TS19100220, TS19110109, TS19110285, TS19110331, TS19120316, TS20050031, TS20050139 Additional Affected Lots as of 10/20/20: TS20050169, TS20050262, TS20060005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2918-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2912-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2913-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2914-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2915-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2916-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2917-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2918-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28
Z-2919-2020	Class II	Completed	Voluntary: Firm initiated	2020-09-09	2020-08-28

Product code KGO

K001924Class ICoated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content Labeling Claim (50 Microgram or Less0Allegiance Healthcare Corp. / cleared 2000-07-14

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)