FDA (Devices) recall action 67454

KCI USA, INC. recalled 8 products on 2014-03-12

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2014-03-12
Critical: 0
Units: 166,800

Why these products were recalled

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

ModerateFDA (Devices)··2014-03-12
KCI Recalls Prevena Dressing Kits Due to Connector Connection Difficulty
KCI USA is recalling 20,850 Prevena Dressing kits because the tubing connector is difficult to connect to the canister.
Product
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
Category
Distribution
0 states
ModerateFDA (Devices)··2014-03-12
KCI Recalls Prevena Customizable Dressing Due to Connector Difficulty
KCI USA is recalling 20,850 units of Prevena Customizable Dressing 5-Packs because the tubing connector is difficult to attach to the canister.
Product
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and remo
Category
Distribution
0 states
ModerateFDA (Devices)··2014-03-12
KCI USA Recalls Prevena Peel and Place System Kits
KCI USA is recalling Prevena Peel and Place System Kits because the tubing connector is difficult to connect to the canister.
Product
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removi
Category
Distribution
0 states
ModerateFDA (Devices)··2014-03-12
KCI Recalls Prevena Incision Management System Kits Due to Connector Issues
KCI USA is recalling Prevena Incision Management System kits because the male tubing connector is difficult to attach to the female canister connector.
Product
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and r
Category
Distribution
0 states
ModerateFDA (Devices)··2014-03-12
KCI USA Recalls Prevena Customizable Dressing 5-Pack Due to Connector Issue
KCI USA is recalling 20,850 units of the Prevena Customizable Dressing 5-Pack because the male connector on the tubing is difficult to connect to the female connector on the canister tubing.
Product
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
Category
Distribution
0 states
ModerateFDA (Devices)··2014-03-12
KCI Recalls Prevena Dressing Kits Due to Connector Connection Issues
KCI USA is recalling 20,850 Prevena Dressing kits because the male tubing connector is difficult to connect to the female canister connector.
Product
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the ap
Category
Distribution
0 states
ModerateFDA (Devices)··2014-03-12
KCI Prevena Peel and Place System Kit Recalled for Connector Issues
KCI USA is recalling Prevena Peel and Place System Kits because the male tubing connector is difficult to connect to the female canister connector.
Product
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates
Category
Distribution
0 states
ModerateFDA (Devices)··2014-03-12
KCI Recalls Prevena Incision Management System Due to Connector Difficulty
KCI USA is recalling 20,850 units of the Prevena Incision Management System because the tubing connector is difficult to attach to the canister.
Product
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed envir
Category
Distribution
0 states