RecallRadar

FDA Device recall Z-0969-2020

Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329

On 2020-02-12 the FDA classified a Class II recall of Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329 by Cook, citing the wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0969-2020
ClassificationClass II
Statusterminated
Initiated2019-01-04
Published2020-02-12
Last updated2026-09-13 11:55 UTC
CompanyCook
DistributionUS

Product

Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329

Reason

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Identifiers

code_info8112670 8113259 8113260 8113261 NS8070847 8076035

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0969-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.