Z-0456-2019Class II

Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered...

Name: Z-0456-2019 Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered...
Creator: American Contract Systems, Inc.
Published: 2016-12-28
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2016-12-28 / Terminated

FDA source

American Contract Systems, Inc. began a recall of Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits... on 2016-12-28. FDA classified it as Class II and gives the reason as "Powdered Surgical Gloves are an FDA banned substance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0456-2019
Classification: Class II
Status: Terminated
Initiated: 2016-12-28
Posted: 2018-11-14
Terminated: 2018-11-14
Recalling firm: American Contract Systems, Inc.
Product: Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.
Product code: KGO Surgeon'S Gloves
Reason for recall: Powdered Surgical Gloves are an FDA banned substance.
FDA root cause: Other
Action: The firm, ACS, notified Customers via phone call and email on about 12/28/2016. The customers were informed about the product, problem and actions to be taken. The customers were instructed to identify and remove all the affected kits for replacement of the recalled gloves; tray insert label must reflect the omission of the powered gloves; and ban, quarantine and return affected product. If you have any questions, contact that Quality Manager at 816-920-5846 or email to: [email protected].
Quantity in commerce: 1,180 kits
Distribution: US Distribution to states of: IL, MO, NE, and OH.
Product codes and lots: Tray Number (Powdered Glove code): MHCE23D (ANS5711104), MHAP41D (ANS7825), MHOC43C (ANS7825), MHPO42D (ANS7825), GVTH071 (ANS5711104), GVTK05L (ANS5711104), GVTK05M (ANS5711104), CXTR68D (ANS5711105), MDEY35H (BAX2D7202I), MDEY35I (BAX2D7202I), FHLV24 (ANS5711105, ANS5711101), LKCA02A (ANS5710503), WIDE32 (ANS7824), UTLU70F (ANS7825), FIOH02H (BAX2D7254)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0456-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0456-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13

Product code KGO

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)