Home / Recalls / Cook Inc. / Z-1370-2019

Z-1370-2019 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

FDA device recall Z-1370-2019 was initiated by Cook Inc. on April 22, 2019 and is designated Class II. Reason for recall: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting. The recall status is terminated (terminated May 5, 2020). Affected quantity: 3711.

Recall Details

Product Type: Devices
Report Date: May 29, 2019
Initiation Date: April 22, 2019
Termination Date: May 5, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3711

Product Description

Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

Reason for Recall

Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.

Distribution Pattern

Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian Federation Czech Republic Greece Jordan Slovakia South Africa United Arab Emirates Slovenia Lithuania Morocco Romania Qatar Bulgaria Libya Saudi Arabia Turkey Ukraine Thailand

Code Information

All lot codes

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