Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number:

FDA device recall Z-2819-2015 · posted 2015-09-28 · Terminated

Recall details

Recalling firm

STERILMED, INC.

Reason for recall

Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.

Action taken

Sterilmed sent an "Urgent Medical Device Recall" letter dated August 24 2015. The letter was addressed to Materials Manger, Risk Manger and Operating Room Supervisor. The letter identified the affected product, problem and actions to be taken. Customers are requested to return all affected product, sign and return the enclosed Customer Response Questionnaire and the Customer Response Form per the instructions on the Forms. For questions contact Sterilmed's Customer Care Team at 888-541-0078.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

KCY

Quantity affected

43

Distribution

US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.

Date initiated

2015-08-24

Date posted

2015-09-28

Date terminated

2016-03-11

Location

Maple Grove, MN