Z-1301-2021Class II

In-View Clear Leggings Sterile Non-Sterile

Name: Z-1301-2021 In-View Clear Leggings Sterile Non-Sterile
Creator: Cardinal Health 200, LLC
Published: 2021-02-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-02-25 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of In-View Clear Leggings Sterile Non-Sterile on 2021-02-25. FDA classified it as Class II and gives the reason as "Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and...". 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-1301-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-25
Posted: 2021-03-24
Terminated: 2024-01-09
Recalling firm: Medtronic, Inc.
Product: In-View Clear Leggings Sterile Non-Sterile
Product code: ILG Stocking, Elastic
Reason for recall: Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A Recall notification letter titled, "URGENT MEDICAL DEVICE RECALL" was sent to consignees on 02/25/2021 via FedEx priority overnight. The consignee is requested to follow the following instructions: 1. CHECK all storage and usage locations to confirm whether they have any units of the affected product codes and lot numbers listed in Attachment 1. 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 they have quarantined. They are requested to please respond regardless of whether or not they have affected product. 4. NOTIFY any customers to whom they may have distributed, or forwarded product affected by this recall. The consignee's notification to their 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. 6. CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it.
Quantity in commerce: 1020 units
Distribution: Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and Canada.
Product codes and lots: Catalog Number 8430N; Lot number's: 3290DR1 and 3300DR1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1301-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1300-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-24
Z-1301-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-24
Z-1302-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-24
Z-1303-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-24
Z-1304-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-24

Product code ILG

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)