Ethicon Mersilene Tape Recalled for Incorrect Instructions for Use Insert
Ethicon, Inc. is recalling Mersilene Tape products because certain product codes were supplied with an incorrect Instructions for Use (IFU) insert.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as an incorrect Instructions for Use insert, which aligns with the rubric criterion for minor labeling errors or documentation issues.
Plain-English summary
Ethicon, Inc. is recalling Mersilene Tape, also referred to as Mersilene Polyester Fiber Strip or Mersilene Fiber Ligature. The recall involves 396,024 units distributed nationwide in the United States, including Puerto Rico.
The recall was initiated because a group of Mersilene Tape product codes were supplied with an incorrect Instructions for Use (IFU) insert. The affected product codes include Mersilene RS20, RS21, RS22, RS23, D10076, D10117, D5789, D7164, D8014, D8062, D8113, and D9212. All unexpired lots of these specific codes are included in the recall.
Healthcare providers and facilities should check their inventory for these specific product codes and stop using the affected products. Users should contact Ethicon, Inc. for further instructions on how to handle the recalled items.
The recalled product
- Product
- ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Suture
- Hazard
- Affected units
- 396,024
Distribution
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