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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Infravision

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  Class 2 Device Recall Stryker Infravision see related information
Date Initiated by Firm May 11, 2010
Date Posted February 01, 2011
Recall Status1 Terminated 3 on February 01, 2011
Recall Number Z-1002-2011
Recall Event ID 56357
510(K)Number K983220  
Product Classification endoscopy accessory - Product Code FAT
Product Stryker Endoscopy, Infravision Esophageal Kit,
Model Numbers: 220180548, 220180540, 220180560
Code Information PSTR010710-1, PSTR081109-1, PSTR081109-2, PSTR081209-1, PSTR081309-2,  PSTR082109-1, PSTR082709-1, PSTR082809-1, PSTR090809-1, PSTR091809-1,  PSTR091809-2, PSTR092409-1, PSTR100309-1, PSTR100909-1, PSTR110609-1,  PSTRI20709-2, PSTR121809-1, PSTR122209-1, STR021009-8R, STR022709-1R,  STR022709-2R, and STR041709-4R  
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact
408-754-2124
Manufacturer Reason
for Recall		 The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
FDA Determined
Cause 2		 Device Design
Action On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.
Quantity in Commerce 4125
Distribution Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland).
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.
510(K) Database 510(K)s with Product Code = FAT and Original Applicant = Stryker Endoscopy
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