CLASS III Device recall · Reported 23 Mar 2022 · FDA Enforcement Report

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box recalled

CellEra is recalling 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box, distributed nationwide in the US. The recall was initiated on 15 Dec 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 200999 GTIN 10856276008649, 00856276008642, 00856276008635

Quantity recalled30,000 ea

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0801-2022
FDA event ID: 89453
Recalling firm: CellEra, Monroe, OH
Classification: Class III
Status: Terminated
Recall initiated: 15 Dec 2021
FDA classified: 16 Mar 2022
Reported: 23 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Dec 2021	Recall initiated by company
16 Mar 2022	Classified by FDA	+91 days
23 Mar 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box recalled?

Yes. CellEra recalled 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box on 15 Dec 2021. The recall is Class III and its status is Terminated. Recall number Z-0801-2022.

Why was it recalled?

Which lots are affected?

Lot 200999 GTIN 10856276008649, 00856276008642, 00856276008635

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CellEra

All 6

Reported	Class	Recall	Company	Reason	Where
23 Mar 2022Device	CLASS III	20548 Vitale Silver calcium Alginate Dressings , 5/box recalled	CellEra	Other	Nationwide
23 Mar 2022Device	CLASS III	20544 Vitale Silver calcium Alginate Dressings , 10/box recalled	CellEra	Other	Nationwide
23 Mar 2022Device	CLASS III	20522 Vitale Silver calcium Alginate Dressings , 10/box recalled	CellEra	Other	Nationwide
23 Mar 2022Device	CLASS III	20545 Vitale Silver calcium Alginate Dressings , 10/box recalled	CellEra	Other	Nationwide
31 Jul 2019Device	CLASS II	Vitale Silicon Foam Dressings 4"x4" recalled by CellEra	CellEra	Other	OH, PA, VA

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