Neomend Recalls Progel Pleural Air Leak Sealant Due to Incorrect Expiration Date
Neomend Inc is recalling 95 units of Progel Pleural Air Leak Sealant because the product was labeled with an incorrect expiration date.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Neomend Inc is recalling 95 units of Progel Pleural Air Leak Sealant, Model PGPS002, Lot 111202-002. The product was distributed nationwide in the United States.
The recall was initiated because the product was labeled with an incorrect expiration date. The label indicated an expiration date of 2013-04, but the correct expiration date should have been 2012-09.
The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure of visible air leaks incurred during open resection of lung parenchyma. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples…
- Manufacturer
- Neomend Inc
- Hazard
- Affected units
- 95
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 (1)
- Model #: PGPS002 Lot #: 111202-002
Distribution
Distributed nationwide across the United States.
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