CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number

FDA device recall Z-0933-2015 · posted 2015-01-07 · Terminated

Recall details

Recalling firm

KCI USA, INC.

Reason for recall

KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.

Action taken

KCI sent an Urgent - Voluntary Medical Device Field Notification letter to all affected consignees on December 8, 2014. The letter notified the customer of the issue, and provided instructions to inspect their harvester prior to use. If blade drift is identified, instructionswere provided to the customer to either return the device to KCI, or if they wish, how to reset the blade prior to use. The letter instructs the customer to respond to the recall notifcation by returning the product reconciliation form attached the letter. Follow-up notifcations will be send to non-responding consignees. Consignees with questions were instructed to contact their local KCI Representative or Customer Technical Service Center at 1-800-275-4524 and select option 3. For questions regarding this recall call 210-515-4108.

Root cause

Device Design

Status

Terminated

Product code

GFD

Quantity affected

1,139/5 Packs

Distribution

Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE,

Date initiated

2014-11-19

Date posted

2015-01-07

Date terminated

2015-09-18

Location

San Antonio, TX