CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

FDA device recall Z-2717-2014 · posted 2014-09-29 · Terminated

Recall details

Recalling firm

KCI USA, Inc.

Reason for recall

Blade can shift during shipping which makes the product ineffective.

Action taken

KCI sent an Urgent - Voluntary Medical Device Field Notification letter dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is sending Field Notifications to affected customers instructing them to complete appropriate actions. Option I: Contact your local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected harvester(s). Option 2: If you prefer, you may re-set the blade after removal from the packaging by gently tapping the curved end of the harvester against the palm of your hand, as shown in Figure 3, until the blade is no longer visible in the harvester top plate, as shown in Figure 4.

Root cause

Device Design

Status

Terminated

Product code

GFD

Quantity affected

1,331 units

Distribution

US nationwide Distribution

Date initiated

2014-05-19

Date posted

2014-09-29

Date terminated

2015-09-18

Location

San Antonio, TX