Z-0801-2022Class III

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

Name: Z-0801-2022 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Creator: CellEra LLC
Published: 2021-12-15
License: https://open.fda.gov/license/

CellEra, LLC / initiated 2021-12-15 / Terminated / root cause: labeling and UDI

FDA source

CellEra LLC began a recall of 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box on 2021-12-15. FDA classified it as Class III and gives the reason as "Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0801-2022
Classification: Class III
Status: Terminated
Initiated: 2021-12-15
Posted: 2022-03-16
Terminated: 2023-10-16
Recalling firm: CellEra, LLC
Product: 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Product code: FRO Dressing, Wound, Drug
Reason for recall: Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On December 15, 2021, the firm notified customers who had received product from CellEra within the past six months. The firm requested these customers hold any merchandise on hand pending receipt of replacement IFU's. The firm communicated with those companies to determine how many new IFU's they require for their inventory and for their customers.
Quantity in commerce: 30,000 ea
Distribution: US Nationwide distribution.
Product codes and lots: Lot 200999 GTIN 10856276008649, 00856276008642, 00856276008635

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0801-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0801-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0802-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0803-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0804-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-16
Z-0805-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-16

Product code FRO

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)