FDA Device recall Z-2622-2016
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal…
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal… by Cook, citing increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2622-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | US |
Product
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Reason
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications 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.
Identifiers
| code_info | All Lots. Catalog/product number; Global/order number BBFS-100 G26088 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2622-2016%22
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