Cook, Inc. THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label)
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lot E2026214.
Products Sold
Lot E2026214.
Cook, Inc. is recalling THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter ex due to The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whet. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.
Recommended Action
Per FDA guidance
Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026