Z-2032-2021Class II

Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N -

Name: Z-2032-2021 Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N -
Creator: Cardinal Health 200, LLC
Published: 2021-05-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-05-21 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to... on 2021-05-21. FDA classified it as Class II and gives the reason as "The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2032-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-21
Posted: 2021-07-08
Terminated: 2024-01-08
Recalling firm: Medtronic, Inc.
Product: Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
Product code: PUI Drape, Surgical, Exempt
Reason for recall: The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall by letter on 05/20/2021. The letter explained the issue and the hazard, and requested the return of the units.
Quantity in commerce: 26250 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers: 0141ER1, 0141ER2, 2400ER2, 2410ER1, 2410ER2, 2540ER2, 2550ER1, 2550ER2, 2580ER1, 2580ER2, 2590ER1, 2590ER2, 2600ER1, 2760ER2, 2880ER1, 2940ER1, 2940ER2, 3070ER1, 3080ER1, 3530ER1, 3530ER2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2032-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2031-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2032-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2033-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2034-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2035-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2036-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2037-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08
Z-2038-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-08

Product code PUI

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)