CooperSurgical Recalls 5 mm Apple-Hunt Secondary Cannulas Due to Packaging Error
CooperSurgical, Inc. is recalling 520 units of 5 mm Apple-Hunt Secondary Cannulas because they were packaged with the wrong trocar length type.
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, and the source text identifies the issue as a packaging error (wrong length type) without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CooperSurgical, Inc. is recalling 520 units of 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count), Model Number 900-840. The recall was initiated because the products were packaged with the wrong trocar length type.
The affected products are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. The recall covers Lot number 223333.
The products were distributed worldwide, including in the United States (Florida, Georgia, Indiana, New Jersey) and in Canada, Austria, Chile, Italy, and Singapore. Users should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic…
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 520
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)
- Lot number 223333
Distribution
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