Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Check against the official notice below — it lists the full affected range.
Cook Inc. is recalling 45 Torcon NB Advantage Catheters due to a potential compromise of sterility caused by an undersealed chevron in the packaging pouches. These catheters are intended for use by trained physicians in peripheral and coronary vascular procedures, including those involving the carotid arteries. The recalled product has a lot number of 9930261 and was distributed worldwide, including throughout most U.S. states and multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom.
The recall affects a specific product lot identified by REF number HNB5.0-NT-80-P-NS-MPA and GPN G10354. The source document does not specify a remedy or recommended action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Reason for recall: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB. Quantity: 45 Lot/code info: REF (RPN): HNB5.0-NT-80-P-NS-MPA REF (GPN): G10354 Lot Number: 9930261 UDI: (01)00827002103542(17)220812(10)9930261
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.