Cook Inc.: Medical Device Recall in 2019 - (Recall #: Z-1369-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr AQ-003600 G17151; 7.0 Fr AQ-003700 G17152

Product Classification:

Class II

Date Initiated: April 22, 2019

Date Posted: May 29, 2019

Recall Number: Z-1369-2019

Event ID: 82795

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.

Status: Terminated

Product Quantity: 12968

Code Information:

All lot codes

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

Voluntary or Mandated:

Voluntary: Firm initiated