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U.S. Department of Health and Human Services

Class 2 Device Recall Tourniquet Cuffs

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  Class 2 Device Recall Tourniquet Cuffs see related information
Date Initiated by Firm August 08, 2008
Date Posted January 13, 2009
Recall Status1 Terminated 3 on April 26, 2011
Recall Number Z-0572-2009
Recall Event ID 49510
Product Classification Pneumatic tourniquet - Product Code KCY
Product 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.
Code Information n/a
Recalling Firm/
Manufacturer		 Sterilmed Inc
11400 73rd Ave N Ste 100
Osseo MN 55369-5562
For Additional Information Contact
763-488-3400
Manufacturer 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
FDA Determined
Cause 2		 Packaging process control
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.
Quantity in Commerce 1565
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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