Medical dressing recall issued due to incorrect instructions for use
CellEra LLC recalls Vitale Silver calcium Alginate Dressing Ropes due to incorrect Instructions for Use in product packaging. The manufacturer is replacing affected units with corrected instructions.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Class III FDA medical device recall involving a documentation issue: incorrect Instructions for Use with language beyond FDA clearance. No reported illnesses, injuries, or product defects. Meets the rubric criterion for documentation issues rated Low.
Plain-English summary
CellEra LLC is recalling the 20500 Vitale Silver calcium Alginate Dressing Ropes (5 units per box) due to incorrect Instructions for Use included in the product packaging. Approximately 30,000 units with lot number 200999 were distributed nationwide.
The recalled dressing packages contain an incorrect version of the Instructions for Use that includes language exceeding what was approved by the FDA in the original 510(k) clearance. CellEra LLC identified this discrepancy and is replacing the affected products with correct, FDA-approved instructions.
Customers who received affected products should contact CellEra LLC to obtain replacement packaging with the proper Instructions for Use. Using the correct instructions ensures the dressing is applied and used safely and effectively.
Healthcare facilities and distributors are advised to stop distribution of the affected lot and notify their customers to request the corrected version.
The recalled product
- Product
- 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
- Manufacturer
- CellEra LLC
- Hazard
- Affected units
- 30,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 200999 GTIN 10856276008649
- 00856276008642
- 00856276008635
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by CellEra LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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