COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Open FDA's page for this record- Cfres ID
- 218917
- Product res number
- Z-1777-2026
- Event date initiated
- 2026-03-05
- Event date posted
- 2026-04-06
- Recall status
- Open, Classified
- Res event number
- 98495
- Product code
- DQX
- Firm FEI number
- 1820334
- Recalling firm
- Cook Incorporated
- Address 1
- 750 N Daniels Way
- City
- Bloomington
- State
- IN
- Postal code
- 47404-9120
- Additional info contact
- Cook Medical Customer Relations Department 812-457-4500
- Reason for recall
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Root cause description
- Incorrect or no expiration date
- Product quantity
- 75 units
- Distribution pattern
- Worldwide distribution.
- Product description
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
- Code info
Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)290214(10)15898546X, Lot Number 15898546X; Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)270115(10)15660224, Lot Number 15660224; Reference Part Number CMW-14-300-18G, UDI (01)00827002507920(17)260718(10)15220204, Lot Number 15220204.
- Action
Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- Harmonized identifiers (openFDA)
- Device name
- Wire, Guide, Catheter
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1330
- Device class
- 2
- K number
- K193194, K882507, K091385, K153106, K924202, K973845, K871517, K101985, K141295, K954552, K253146, K201690, K260544, K873972, K921702, K010497, K160594, K130588, K922787, K841926, K063695, K151840, K902153, K032411, K201834, K112381, K946240, K083145, K972944, K860430, K042370, K122590, K890807, K903923, K121776, K232578, K880332, K864058, K212167, K123792 +728 more
- Registration number
- 3009564766, 1319211, 3020778, 3030733800, 3020954746, 3004091615, 3009380063, 1223004, 1220452, 2518902, 3010041511, 3014716786, 3009756153, 3030446844, 2134265, 3006082230, 3015173212, 3003768277, 3014162263, 3012050423, 1450662, 2527072, 2030624, 8043892, 3008114965, 3010882065, 3006010712, 3013611763, 3012536737, 3014579161, 1313046, 1721504, 3009211636, 2020394, 3005737652, 1282497, 1225687, 2029214, 3041276591, 2939520 +220 more
- FEI number
- 3009564766, 1319211, 3020778, 3030733800, 3020954746, 3004091615, 3009380063, 1220452, 3001632632, 2518902, 3010041511, 3014716786, 3009756153, 1000512168, 3030446844, 3003407487, 3006082230, 3015173212, 3014162263, 3012050423, 1450662, 2527072, 3002947440, 3002807725, 3008114965, 3002902735, 3006010712, 3013611763, 3012536737, 3014579161, 1313046, 1721504, 3002913962, 3009211636, 2020394, 3002807095, 3005737652, 1282497, 3041276591, 2939520 +219 more