Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Ki

FDA device recall Z-0850-2014 · posted 2014-01-28 · Terminated

Recall details

Recalling firm

Kimberly-Clark Corporation

Reason for recall

Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.

Action taken

The firm, Kimberly-Clark Corporation, sent an "URGENT: Voluntary Medical Device Recall Notification" letter dated October 29, 2013 to all direct customers and distributors via federal express priority overnight. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate your Facility's inventory of Kimberly-Clark RadiOpaque Radiofrequency Cannula to determine if any of the two impacted product lots remain within your facility. If product is present, discontinue use of the impacted product and place in a quarantined location; complete and return the attached Product Recall Response Form-Customers via fax to: 1-920-225-4182 within five (5) business days of receipt of this letter (complete and return form even if either of the impacted product lots is NOT present in your facility). Once response form is received, a Kimberly-Clark representative will contact you regarding return and replacement of the product. If you require further assistance, please call Kimberly-Clark Customer Service at 800-KC-HELPS (800-524-3577).

Root cause

Employee error

Status

Terminated

Product code

GXI

Quantity affected

55 cases (10 units per case = 550 units)

Distribution

US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.

Date initiated

2013-10-29

Date posted

2014-01-28

Date terminated

2014-09-03

Location

Roswell, GA

Related 510(k) clearances