Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture
Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (tip fracture/separation) that can lead to significant injury, such as embolization or occlusion of blood flow, meeting the criteria for a Severe rating.
Plain-English summary
Cook Inc. is recalling 52,756 units of the Liver Access and Biopsy Needle Set, a biopsy needle kit intended for obtaining liver histology samples via a jugular vein approach. The recall is due to an increase in reports of polymer degradation of the catheter tip, which can result in tip fracture and/or separation.
The degradation could lead to loss of device function or the separation of a device segment, requiring medical intervention. Complications from separated segments include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
The affected products were distributed worldwide, including in the United States and numerous international locations. The recall covers all lots with catalog prefixes LABS, specifically catalog numbers LABS-100, LABS-200, and LABS-200-CHP-A.
The recalled product
- Product
- Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Biopsy Needle
- Affected units
- 52,756
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)
- All Lots. Catalog prefixes LABS Catalog/product number
Distribution
Part of a larger recall action
This product is one of 14 recalled by Cook Inc. 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.
See all 14 products in this recall →Related recalls
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