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.
This recall has been terminated (originally issued March 4, 2010).
- Company
- Thomas Medical Products Inc
- Recall Initiated
- February 1, 2010
- Posted
- March 4, 2010
- Terminated
- January 5, 2011
- Recall Number
- Z-0815-2010
- Quantity
- 13,973 units
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Radiopaque tip may fracture
Distribution
Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom.
Lot / Code Info
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.
Root Cause
Component design/selection
Action Taken
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.