GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a c…
Terumo Medical Corporation · Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Open FDA's page for this record- Cfres ID
- 221192
- Product res number
- Z-2930-2026
- Event date initiated
- 2026-06-15
- Event date posted
- 2026-08-10
- Recall status
- Open, Classified
- Res event number
- 99285
- Product code
- DYB
- Code info
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- Firm FEI number
- 1118880
- Recalling firm
- Terumo Medical Corporation
- Address 1
- 950 Elkton Blvd
- City
- Elkton
- State
- MD
- Postal code
- 21921-5322
- Additional info contact
- Kimberly Feitl `-800-2837866
- Reason for recall
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Root cause description
- Under Investigation by firm
- Product quantity
- 7,490 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Canada.
- Product description
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
- Action
Terumo Medical Corporation notified consignees on about 06/15/2026. Consignee were instructed to immediately isolate the affected lot number, 0001441871, arrange for the return of those affected units, notify any facilities or customers to which affected units have been further transferred or distributed, and complete and return the provided response form.
- K numbers
- K173831
- Harmonized identifiers (openFDA)
- Device name
- Introducer, Catheter
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1340
- Device class
- 2
- K number
- K900658, K181855, K160716, K254248, K123714, K864352, K040552, K172099, K792170, K920998, K111747, K142245, K930801, K201116, K023447, K873727, K153430, K122431, K010913, K200258, K001367, K994252, K073434, K171609, K101883, K911236, K897041, K911794, K243061, K000004, K894431, K101784, K812143, K861082, K902251, K945524, K231227, K113849, K994334, K123618 +666 more
- Registration number
- 1224960, 9617604, 9616666, 3013162291, 3011657089, 1526711, 3012050423, 3005580113, 1828424, 3005334138, 1835568, 9617592, 3010220595, 1000121056, 3031983053, 3010041511, 3004111573, 1644312, 9610825, 3017060084, 1820334, 3008514120, 3011063223, 3010421104, 2527072, 3042279517, 1647149, 3019751610, 2134244, 3013986346, 3007882731, 3030733800, 3005994106, 1643817, 3039454510, 2020394, 1048735, 3035111606, 3022815697, 1450662 +238 more
- FEI number
- 3003407487, 3003528016, 3005580113, 3013162291, 3011657089, 1526711, 3012050423, 1828424, 3005334138, 3004970277, 3010220595, 1000121056, 3000215205, 3031983053, 1000514656, 3010041511, 3004111573, 3017060084, 3002827704, 1820334, 3008514120, 3011063223, 3010421104, 2527072, 3042279517, 3003565456, 3019751610, 3013986346, 1000123180, 3007882731, 3030733800, 3005994106, 1643817, 3039454510, 2020394, 1048735, 3002808050, 3035111606, 1000518731, 3022815697 +238 more