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U.S. Department of Health and Human Services

Class 1 Device Recall Transseptal Sheath Introducer Kits

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  Class 1 Device Recall Transseptal Sheath Introducer Kits see related information
Date Initiated by Firm February 01, 2010
Date Posted March 04, 2010
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-0815-2010
Recall Event ID 54525
510(K)Number K040713  
Product Classification Introducer, catheter - Product Code DYB
Product Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton.

Intended to allow left heart catheterization procedure to occur through the right atrium.
Code Information Catalog Numbers: XD252500, XD252501, XD252502, XD252503, XD252504, XD252505, XD252506, XD252507, XD252508, XD252509, TF8-38-62-5, TF8-38-62-B1, FCL-127-00, FCL-127-01, FCL-127-02, FCL-127-03, FCL-127-04, FCL-127-05, FCL-127-06, FCL-127-07, FCL-127-08 and FCL-127-09; and  Lot Numbers: 25346, S20361, S20361X1, S20362, S20362X1, S20452, S20501, S20501X1, S20502, S20502X1, S20503, S20504, S20971, S20980, S21218, S21218X1, S21244, S21270, S21270X1, S21271, S21272, S21273, S21278, S21571, S21828, S21903, S21904, S21905, S21906, S21940, S21973, S22005, S22019, S22020, S22057, S22088, S22094, S22095, S22096, S22107, S22108, S22235, S22236, S22237, S22237X1, S22238, S22239, S22240, S22241, S22242, S22243, S22246, S22495, S22496, S22497, S22498, S22598, S22613, S22614, S22670, S22677, S22739, S22739X1, S22754, S22871, S22880, S22890, S22908, S22939, S22950, S23012, S23163, S23380, S23400, S23401, S23449, S23454, S24213, S24759, S25171, S25393, S25536, S25618 S25647, S26047, S26129, S26480, S26969, S26970, S27089, S27367, S27368, S27369, S27466, S27587, S27631, S27632, S27647, S27767, S27768, S27772, S27953, S27966, S28055, S28539, S28555, S28587, S28796, S29034, S29035, S29527, S29659, S29660, S29934, S30137, S30427, S30428 and S30519.
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Customer Service
866-446-3003
Manufacturer Reason
for Recall		 Radiopaque tip may fracture
FDA Determined
Cause 2		 Component design/selection
Action Thomas Medical Products, A GE Healthcare Company, issued an "Urgent Medical Device Correction" letter dated February 1, 2010. Consignees were informed of the affected product then asked to cease distribution, return any product to firm and contact all sub-accounts. For further information, contact Thomas Medical Products Customer Service at 1-866-446-3003.
Quantity in Commerce 13,973 units
Distribution Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom.
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 = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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