The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2622-2016·Announced 2016-08-31

Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture

Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps 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 source text describes potential complications including device fragments in the vascular system, embolization to the heart or lungs, and occlusion of blood flow to end organs. These represent significant injury risks, which aligns with the rubric criterion for a score of 4 (Severe) involving significant injury reports or structural defects.

Plain-English summary

Cook Inc. is recalling 2,606 units of the Transluminal Biliary Biopsy Forceps Set (Catalog number BBFS-100, Global order number G26088). The device is a non-electric forceps intended for access to and biopsy of tissue within the biliary ductal system. The recall covers all lots and includes units distributed nationwide in the United States and internationally to numerous countries.

The recall is being issued due to an increase in reports of polymer degradation of the catheter tip, which can result in tip fracture and/or separation. This degradation can lead to a loss of device function or the separation of a device segment, which may require medical intervention. Complications from separated segments can include device fragments remaining 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. Because this is a Class II recall, the FDA has determined that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Manufacturer
Cook Inc.
Category
Medical Device — Biopsy Forceps
Hazard
Affected units
2,606

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 (2)

  • All Lots. Catalog/product number
  • Global/order number BBFS-100 G26088

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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

Same manufacturer · Cook Inc.

See all →

Same hazard · device fracture

See all →

Similar recalls