Z-0838-2022Class II

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Name: Z-0838-2022 Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Creator: Ansell Healthcare Products LLC
Published: 2022-02-19
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2022-02-19 / Open, Classified

FDA source

Ansell Healthcare Products LLC began a recall of Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 on 2022-02-19. FDA classified it as Class II and gives the reason as "Transport company failed to stop at the border for required FDA inspection". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0838-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-19
Posted: 2022-03-30
Recalling firm: Ansell Healthcare Products LLC
Product: Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Product code: KGO Surgeon'S Gloves
Reason for recall: Transport company failed to stop at the border for required FDA inspection.
FDA root cause: Other
Action: On 02/19/2022, the Recalling Firm initiated notification via email to its Distribution partners and requested that they reach out to their end user customers. The Recalling Firm informed its customers that between February 2nd to 10th, 2022, it shipped Non-Latex surgical gloves with LOT Number 2107481604 and Manufacturing Date 2021-08-05 to some of its distributor partners. As a part of their warehouse inventory rebalancing procedures within North America, the product was transferred from their Canadian warehouse to one of their USA warehouses. When importing into the US, the freight forwarder inadvertently bypassed a required FDA inspection. After arriving at the USA warehouse, product was shipped prematurely. Customers/Distributors are asked to: 1. Search their system/inventory to identify if affected products are currently in their possession. A visual guide is provided to assist with identifying the impacted product. 2. If impacted products are found in their system/inventory, they are to return the impacted products back to the Recalling Firm, and replacements were be provided free of charge. For questions or assistance in returning the products, contact Customer Service at 1-855-868-5540 or email [email protected].
Quantity in commerce: 74 cases
Distribution: U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
Product codes and lots: Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0838-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0838-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-30

Product code KGO

K111139Class IDerma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for UAnsell Healthcare Products, Inc. / cleared 2011-09-02

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)