Cook Inc. Recalls LapSac Surgical Tissue Pouches Due to Labeling Error
Cook Inc. is recalling 123,184 LapSac Surgical Tissue Pouches because the labeling includes information not stated in the intended use.
What this means for you
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 specific hazard is a labeling error ('Includes Information not stated in the intended use') with no reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate severity score.
Plain-English summary
Cook Inc. is recalling 123,184 units of the LapSac Surgical Tissue Pouch. The device is a reinforced pouch with an inner liner and drawstring closure, intended for isolating tissue during or prior to surgical removal and/or morcellation. The recall is due to a labeling issue where the product includes information not stated in the intended use.
The affected devices were distributed worldwide, including nationwide in the United States and in several international markets. The recall covers multiple lot numbers across various product configurations, including the LapSac Surgical Tissue Pouch, LapSac Pre-Loaded Surgical Tissue Pouch Introducer, and LapSac Tissue Entrapment Pouch.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement.
The recalled product
- Product
- LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used t
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 123,184
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 (20)
- RPN: C-LSP-10-8
- LapSac Surgical Tissue Pouch
- LapSac Pre-Loaded Surgical Tissue Pouch Introducer
- LapSac Tissue Entrapment Pouch
- LapSac Tissue Entrapment Pouch Introducer
- Lot Numbers: NS4993649
- NS5439526
- NS5068444
- NS5145395
- NS5423474
- UF2481538
- NS5257887
- NS4966724
- UF2282980
- NS5477239
- NS4945215
- NS5054749
- NS5012363
- NS5835007
- NS5047552
Distribution
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