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Terminated

Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103 A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff.

FDA Recall Z-0572-2009 · Posted 2009-01-13

Recalling FirmSterilmed Inc
Recall StatusTerminated
Product CodeKCY
Date Initiated2008-08-08
Date Terminated2011-04-26
Product Quantity1565

Reason for Recall

SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

Firm Action

Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

Root Cause

Packaging process control

Distribution Pattern

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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