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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Wire Caddy

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  Class 2 Device Recall Stryker Wire Caddy see related information
Date Initiated by Firm May 27, 2011
Date Posted July 06, 2011
Recall Status1 Terminated 3 on August 03, 2011
Recall Number Z-2746-2011
Recall Event ID 58907
Product Classification Instrument, manual, surgical, general use - Product Code MDM
Product Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210.

This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.
Code Information Lots 10306012, 10323012, 10340022, 11007012 and 11047012
Recalling Firm/
Manufacturer		 Stryker Instruments Division of Stryker Corporation
4100 East Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact Jennifer Mars
269-389-7700
Manufacturer Reason
for Recall		 The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission.
FDA Determined
Cause 2		 Material/Component Contamination
Action Stryker Instruments sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to quarantine affected product and return the recalled product using the shipper supplied to them by Stryker. Replacements will be issued to customers upon receipt of the product. For questions regarding this recall please call 1-800-800-4236 ext. 3808.
Quantity in Commerce 87 boxes, 435 untis
Distribution Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.
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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